Qc Chemist Resume Samples
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Qc Chemist Resume Samples
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A Deckow
Aurelio
Deckow
164 Merl Inlet
New York
NY
+1 (555) 616 0730
164 Merl Inlet
New York
NY
Phone
p
+1 (555) 616 0730
Experience
Experience
Houston, TX
Qc Chemist
Houston, TX
Barton Inc
Houston, TX
Qc Chemist
- Perform elementary method analysis and development for troubleshooting purposes. Make recommendations to technical support on analytical methods
- Perform other duties as assigned or deemed necessary to assist the QC Lab Manager in achieving key objectives
- Manage daily tasks with in the lab to ensure work queue is managed
- Perform all miscellaneous analytical testing as directed by West Chester’s QC Supervisor, Methods Development Chemist, and Analytical Services Manager
- Perform and assist with additional duties as may be directed by the QC supervisor
- Generate, review and maintain detailed records/documents and assist with QC data management and control charting
- Work in accordance with approved methods, SOPs, and cGMPs/GLPs, while performing tests
Philadelphia, PA
QC Chemist, Raw Material
Philadelphia, PA
Turcotte-Rogahn
Philadelphia, PA
QC Chemist, Raw Material
- Support in establishing and controlling of raw material’s supplier qualification program
- Ensure raw materials have been manufactured, tested or inspected according to specifications and current testing
- Assist in optimizing test procedures to improve efficiency whenever possible
- Preparation and reviewing of equipment qualification protocols and reports
- Establish and maintain QC Raw Materials laboratory in full cGMP-compliance
- Participate in the validation and transfer of internal test methods, as well as method verification of compendial methods
- Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS) and/or Internal Validated Methods
present
Philadelphia, PA
Senior QC Chemist
Philadelphia, PA
Goyette LLC
present
Philadelphia, PA
Senior QC Chemist
present
- Set up, troubleshoot, and make adjustments to laboratory equipment
- Serves as a technical lead on projects and provides direction to various levels of chemist
- Applies cGMP concepts in association with department specific responsibilities
- Performs routine to complex laboratory analyses and experiments with no supervision
- Performs testing for the qualification of reference standards
- Transfer, modify, and improve analytical methods
- Provide technical advice to team members, and other Johnson Matthey Pharma Services (JMPS) departments
Education
Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Seton Hall University
Bachelor’s Degree in Chemistry
Skills
Skills
- Strong knowledge of analytical chemistry principles and methods with the ability to interpret results
- Strong knowledge of wet chemistry and GLP’s
- Ability to perform basic math functions
- Proficient in SAP and Microsoft Office with excellent written and verbal communication skills
- Excellent interpersonal, verbal, and written communication skills with the ability to communicate with all levels of the organization
- Strong command of Quality Control processes/systems
- Good understanding of ISO/AS 9001 Quality Management Systems
- Ability to communicate in a professional manner, both written and orally, with individuals at all levels of the organization
- Ability to use personal judgment and knowledge to disseminate information
- Highly proficient in usage of IT tools – MS Office Suite, SPC, SAP, ETQ, Access, and other computer systems
15 Qc Chemist resume templates
Read our complete resume writing guides
1
Qc Chemist Resume Examples & Samples
- Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP
- Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing
- Ensure all analytical testing is carried out as defined in the Quality System
- Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records
- Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of software in accordance with industry standards
- Management of laboratory spend and approval of vendor invoices
- Management of laboratory inventory and supplies and ordering of same
- Participate on LBP/VIP and Continuous project teams as required
- BSc or similar degree with minimum 3 years experience in a relevant area
- Proven ability to work well as part of a team & on own with minimum supervision
2
Qc Chemist Resume Examples & Samples
- Perform testing, utilizing analytical equipment and standard wet chemistry techniques, on raw materials, intermediate and bulk (including lacquer)
- Write/revise standard operating procedures and methods
- Assist training of other chemists on procedures and processes as needed
- Responsible for calibration, maintenance and troubleshooting of test instruments
- Maintains a clear understanding and working knowledge of GMP/GLP requirements, Safety requirements, test methods and SOP’s. Adheres to and enforces those policies within the team
- Working knowledge of a wide variety of laboratory equipment and processes
- Strong knowledge of wet chemistry and GLP’s
- Process and Method Validation
- Excellent application of Root Cause Problem Solving
- CGMP (Cosmetic Good Manufacturing Practices)
- Technical Writing skills relative to SOPs, Test Methods, and Work Instructions
- Team Oriented
- Effective influence and persuasion skills
- Strong time management and prioritization capability
- Excellence in Execution
- Constructive Networker
3
Qc Chemist Resume Examples & Samples
- To operate within the chemistry laboratory for the analysis of raw materials, in process and finish products
- Sampling of materials, utilities and environment
- Ensure all operations are conducted in accordance with GMP's and good scientific principles
- Manage documentation and equipment maintenance systems within the laboratory
- Review chemical analysis data of raw materials, in process and finish products
4
Bulk QC Chemist Resume Examples & Samples
- Adhere to H&S, Quality, GLP, GMP (ISO 22716) and Hygiene Policies
- Complete all daily activities required within the bulk QC laboratory
- Perform analysis of bulks according to quality and IC/R&D specifications
- Responsible for timely and effective quality testing
- Record, interpret and communicate results. Report results using defined documentation systems/computer systems
- Review and analyze quality results for quality improvements e.g. RFT
- Raise quality notifications and partake in root cause/problem solving investigations
- Maintain bulk retains and Reference Standards
- Create, edit, review and maintain quality control procedures
- Review and manage inventory, raising disposal notes for bulks to be destroyed when necessary
- Partake in internal and external quality/H&S audits
- Present and share information on processes or practices with visitors or external auditors
- Provide quality advice and guidance to central weighing, manufacturing, pressing and assembly departments
- Liaise with IC/R&D
- Provide information and training to new staff
- Contribute to and participate in continuous improvement activities if required (lean events)
- Act today, shape tomorrow, and deliver continuous improvement/lean improvements
- Represent department at key meetings, projects or working groups, delegate for Senior Bulk QC Chemist where necessary
5
Qc Chemist Resume Examples & Samples
- Testing all current finished products using assigned techniques, methods and procedures to agreed timescales
- Complete testing data in accordance with Company Policy and legislative compliance to agreed time scales
- Carry out peer checking of analytical test documentation as required
- Report all OOS and Atypical data and results to the QC Supervisor
- Participate in laboratory investigations as required,
- To prepare and maintain all chemicals and solutions according to current procedures
- Be conversant with the hazardous properties of chemicals and observe the safety rules
- Assist in the management of laboratory stock items
- Maintenance and calibration of instruments
- To give assistance in maintaining and updating laboratory procedures, reports, logbooks, certificates of analysis and other documentation
- To participate in training programmes
- To assist in GMP and safety audits of the laboratory and other areas as required
- Third level degree in science discipline
- Minimum 2-3 years laboratory experience with good hands-on knowledge of common laboratory techniques and instruments including HPLC, GC, Dissolution, KF, LOD, Raw material testing experience is preferred
- Maintain credibility and integrity
- Strong work ethics and goal focused
- Demonstrate enthusiasm and energy
- Software - Empower / Velquest / LIMS
6
QC Chemist Fresno Resume Examples & Samples
- Promptly performs reports and records all Quality Control procedures and test results in a precise and accurate manner
- Maintains inventory status of reagents, equipment, etc. in order to keep the lab at full operational capacity
- Prepares lab standard test reagents, and performs standardization on reagents and calibration of equipment on a regular basis. Keeps detailed records and maintains control and/or trend charts
- Maintains a clean, safe and orderly work environment and assures smooth operation of the QA Laboratory by communication, planning and preparation in support of other shifts. Understands and is active in the company 5S and Lean initiatives
- Associate’s degree in Chemistry or a related field
- Immigration sponsorship not offered for this role
- Bachelor’s degree in Chemistry or other Science preferred
7
Qc Chemist Resume Examples & Samples
- The QC Chemist shall conduct analytical and physical tests on raw materials, drug substances, in-process samples and drug products in accordance with approved procedures, with minimal supervision of the laboratory supervisor
- The incumbent will, on occasion, supervise the work of one or more Technicians, if deemed necessary by the Laboratory Supervisor
- The incumbent should be able to demonstrate a working knowledge of all required analytical techniques used in the Impax QC Laboratory. He/she should be able to perform all required duties independently or with minimal assistance of the lab supervisor
- The incumbent shall assure that products are tested and evaluated in accordance with laboratory SOPs and cGMP regulations and are dispositioned accordingly
- The incumbent should be fully aware of version and change control as they relate to all lab documentation
- He/she shall maintain laboratory instrumentation, logbooks, test results, databases and notebooks in compliance with laboratory SOPs and cGMPs as they relate to the QC Laboratory (i.e., 21 CFR 211.65)
- The incumbent should be fully aware of all USP/NF and other compendial requirements, ICH and FDA Guidances, Corporate laboratory requirements and other policies and procedures as they relate to QC Laboratory activities
- The incumbent will be responsible for providing and documenting training to less experienced laboratory personnel
- The incumbent shall be familiar with software such as Microsoft Word, Microsoft Excel, and other such relevant software packages, such as TotalChrom® and/or other Chromatographic Data and Control software
- He/she maintains a safe work environment for self and others in the laboratory. Assures that all safety information such as MSDSs are available for all lab personnel
- The incumbent may be called upon to perform other tasks to support the attainment of business objectives
- The incumbent is responsible for mentoring less experience lab personnel in good documentation practices (notebook, investigative and other technical report writing, annotating and archiving supporting data, maintaining procedural formats, etc.)
- The incumbent may perform such metrology functions as instrument/system calibration and qualifications
8
Lead / Coordinating QC Chemist Resume Examples & Samples
- Responsible for QC release of finished products and raw materials / analytical project management and delivery
- Responsible for scheduling of workload within the QC labs ensuring that QC metrics are met
- Provide analytical services and support to the site, ensuring compliance to GMP's and SOP's
- Subject matter expert on quality control activities
- Use technical skills and experience to troubleshoot and problem solve product testing issues. Lead lab investigations and deviations
- Ensure QC Laboratories meet current Good Laboratory Practice (cGLP) requirements and ensure always audit ready
- Compile, review and trend chemistry test results on a daily basis to ensure compliance with cGLP
- Stakeholder management with other departments / sites on matters related Quality Control
- Assist and/or lead projects for safety improvements/lean implementation/continuous improvement/compliance
- Assist in testing where required
- 3rd level degree in a science related discipline required (chemistry or biochemistry degree an advantage)
- 5 years + experience gained a cGMP manufacturing laboratory environment within the pharmaceutical sector
9
Qc Chemist Resume Examples & Samples
- Provide analytical services and support to the site, ensuring compliance to GMP's and SOP's. Assist in routine testing procedures in support of team targets
- Use technical skills and experience to troubleshoot and problem solve product testing issues
- Ensure QC Laboratories meet current Good Laboratory Practice (cGLP) requirements
- Maintain, update and issue chemical methods, specifications and SOP's in compliance with pharmacopeia and regulatory requirements
- Compile and review chemistry test results on a daily basis to ensure compliance with cGLP
- Training other team members as required
- Effective interaction with other departments on matters related to raw materials, in-process, packaging and finished batch release
- Assist in method transfer/development activities as required
- 2 years experience gained a cGMP manufacturing laboratory environment - ideally part within the pharmaceutical sector
10
Qc Chemist Resume Examples & Samples
- · Handle internal and external problems related to quality, dig out root cause and propose corrective action and preventive measurements, issue investigation report on time
- · Be an active participant in quality and efficiency improvement projects, design or propose action plan for these projects, implement action plan and monitor project progress as required
- · Recognize customer and statutory specific requirements on products, support supervisor to guarantee compliance
- · Maintain interaction with solution lab and technical service as well as counterparts at other locations
- · Take the coordinating role in work-off activities; make every effort to reduce COPQ
- · Train QC employee with standardized SOP and product information on the job training program
- · Take responsibility to daily maintain lab facilities and organize 5S activities
- · Ensure that all activities in the areas of responsibility comply with the SSHE policy of AkzoNobel
- · Other responsibilities as assigned by supervisor or line Manager
11
Entry Level QC Chemist Resume Examples & Samples
- Under the supervision perform analytical testing of raw materials, in-process materials, stability samples, finished products as per the test method
- Perform wet chemistry testing as per Test Method, SOP or USP compendia procedure
- Analytical testing will include Assay, preservative content, LOD, ROI, water content, identification test, dissolution, disintegration, heavy metals etc
- Operates general analytical instruments during routine testing including but not limited to HPLC, GC, KF /Automatic titrator, FT-IR, Polarimeter, UV/Vis spectrophotometer, melting point apparatus, dissolution and disintegration units, Malvern Particle size analyzer, and laboratory ovens
- Recognizes deviations from normal trend and inform group leader or laboratory management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems
- Complies with all current Good Manufacturing Practices (cGMP) current Good Laboratory Practices (cGLP) and Environmental Health & Safety (EHS) requirements, laboratory Standard Operating Procedures (SOPs) and company policies and procedures
12
Qc Chemist Resume Examples & Samples
- Perform standard qualitative and quantitative analysis on: purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures
- Utilize standard "bench" chemistry technique as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc
- Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms
- Perform routine analytical testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards
- Assist with troubleshooting analytical methodology and instrumentation malfunctions
- Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology (e.g. equipment and room cleaning validation)
- If assigned to the QA Receiving area, develop specifications for packaging components and prepare final specification sheets for new, revised, or updated components in conjunction with packaging departments, other facilities and component vendors
13
Qc Chemist Resume Examples & Samples
- Bachelors in Chemistry/related field or an Associates in Chemistry/related field
- Previous pharmaceutical (cGMP) lab experience preferred
- Experience using fundamental analytical instrumentation and techniques (such as HPLC,GC, viscometer , titration, UV-Vis, IR)
- Computer knowledge and use of Microsoft Office software
- Legible and thorough documentation skills
14
Electronic Chemicals Lab QC Chemist Resume Examples & Samples
- Perform analytical testing of finished products, in-process samples, stability samples, experimental samples, and raw materials in support of manufacturing and product development
- Perform analytical testing using titration, GC, FTIR, and other common chemistry analytical techniques
- Document testing results in accordance with quality procedures and maintain a well-documented laboratory notebook
- Execute method transfer protocols, method validation protocols, investigation protocols, and instrument qualification protocols
- Develop new analytical methods to support product development and technical service
- Maintain awareness of state-of-the-art analytical chemistry technology
- Work in a fast paced, results-oriented team environment to assist in developing new technologies to provide solutions to customers' needs
- Adhere to Dynaloy environmental, health, and safety program
- Perform common laboratory procedures such as weighing on analytical balances, glassware preparation, equipment calibrations, and data review
- Be an immediate contributor
- College degree in Chemistry, Biology, or related field. Graduate degree preferred
- 5 or more years experience in an analytical/QC laboratory setting is required
- Previous experience with GC method development is required
- Previous experience in a wet chemistry laboratory is required
- Previous experience with Quality Control and ISO 9001 is required
- Previous experience performing customer and ISO audits is required
- Strong collaboration skills
- Strong results focus
15
Qc Chemist Resume Examples & Samples
- The QC Chemist shall conduct analytical and physical tests on raw materials, drug substances, in-process samples and drug products in accordance with approved procedures with minimal supervision
- Development of analytical methods of new DP and API by using HPLC, GLC and UV-Vis NIR Spectrophotometer
- Experience maintaining laboratory instrumentation, logbooks, test results, databases and notebooks in compliance with laboratory SOPs and cGMP as they relate to the QC Laboratory
- Experience working with Oral Solids is a must
- Must have excellent interpersonal, communication, and written skill
- Data generated will be utilized to nominate dosage forms
- Bachelor of Science (B.S.) degree in Chemistry is required. A Master of Science (M.S.) degree in Chemistry is preferred
- Three to five years of experience in pharmaceutical quality control laboratory in stability department
- A minimum of 2 years’ experience working in generics environment
16
Qc Chemist Resume Examples & Samples
- Running tests on samples originating from the plant, the field, QC Management, vendors, toll manufacturers, or Global Technology personnel, including making usage decisions on batches of products produced at the plant or lots of raw materials brought into the plant
- Calculating material additions to batches based on test results, and assisting in batch troubleshooting activities
- Taking part in the QC Lab safety program and monthly QC Lab operational meetings
- Characterizing shelf stability of batch retains samples
- Calibrating and maintaining QC Lab equipment
- Administrative activities such as creating certificates of analysis; general laboratory housekeeping activities
- Previous laboratory experience required
- Bachelor’s degree (Chemistry or a related technical field) preferred
- Chemical manufacturing experience a plus
17
Qc Chemist Resume Examples & Samples
- Assists QC Manager with updates of quality systems for analytical testing of raw materials, bulk powder, and finished product
- Develops new methods/techniques, and improves existing test methods, as needed
- Reviews and approves SOPs, analytical data, and corrective action reports
- Assesses any non-conformance/out-of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective action
- Identifies and coordinates qualification of contract testing laboratories as needed
- Follows appropriate protocols, SOPs, compendial and analytical methods, and stability protocols for sampling and testing active pharmaceutical ingredient and finished product
- Maintains appropriate equipment, records, files, and logs according to SOPs and applicable regulatory requirements
- Performs basic diagnostic and troubleshooting procedures for test methods and instrumentation
- Assists in the maintenance of laboratory requirements, including reagents and supplies
- Reviews trending of data and helps to manage sample backlogs
- Bachelor's Degree in Biochemistry, Chemistry, or a related science degree
- Intimate familiarity with instrumental analysis of protein samples (i.e., HPLC, IVD, SDS-PAGE, viscosity, particle size)
- Computer skills (Excel, Word, SmartLab, Empower, LIMS).Method and/or equipment validation experience
- Experience in protein manufacture, highly recommended
18
Qc Chemist Resume Examples & Samples
- Support supervisor to guarantee released batch compliant with available laws and regulations, Understand TS16969 requirements on the position, comply with those requirements in daily works
- Collect data basing on daily work and keep test records for every batch
- Follow all the lab safety rules and AKZO regulations. Be responsible for daily housekeeping and equipment maintenance of working area
- Other responsibilities as assigned by supervisor or line Manager
19
Qc Chemist Resume Examples & Samples
- Perform required testing on raw materials, intermediates and finished products to ensure quality products and customer satisfaction
- Evaluate analytical data and recommend corrective action to production personnel
- Maintain lab assets in accordance with written procedures and schedules as required by GMP, GLP, and ISO 9001 when applicable
- Recommend improvements to existing analytical methods and develop new methods when appropriate
- Assists in maintaining appropriate inventory levels of lab supplies
- Responsible for the approval / rejection of finished product samples for incoming and outbound shipments
- In collaboration with lead operators, provide resolution for activities on the offshift
20
Qc Chemist Resume Examples & Samples
- Responsible for the maintenance of quality related SAP modules (QM and MM)
- Responsible for managing customer and Huntsman product specifications
- Manage non-conforming product system, including blocked inventory
- Transition existing hard copy QC batch data to an electronic system- LIMS, MS Excel, MS Access, etc
- Monitor batch product data with SQC techniques, including process capability studies, to alert production of potential off-spec and advise business and technical teams about specification change opportunities
- Interact with Customer Service and technical teams providing quality related feedback on customer inquires about materials and specification related issues
- Maintain lab instrumentation and calibrations and commission new equipment and instrumentation
- Identify opportunities to continually improve department equipment, techniques and work processes
- Work with Process Development and Technical Innovation (R&D) teams on new product specifications and testing protocols
- Coordinate work assignment and priorities with lab technicians and administrative assistant
- Follows instructions and performs other duties as may be assigned by supervisor
- A minimum of a Bachelor's Degree in Chemistry or related discipline
- 5 years of laboratory experience in a similar role, minimum 2 years of experience with quality management systems: ISO9001 and AS9100, the Aerospace Standard
- Must have a level of proficiency with Internet, Email, and Microsoft programs
- QC Chemist with experience in working in a manufacturing site quality control laboratory
- Good understanding of ISO/AS 9001 Quality Management Systems
- Must have excellent multitasking skills to be able to maintain real time communication between production, planning and customer service in quality related issues
- Proficient in SAP and Microsoft Office with excellent written and verbal communication skills
- Must work closely with external and internal customers and be capable to coordinate laboratory schedule deadlines while adhering to company’s safety guidelines
- Must have a good understanding of mechanical and analytical test methods for materials used in different industrial and aerospace applications
21
Qc Chemist Resume Examples & Samples
- Conduct method validation and round-robin testing in site QC lab for products of manufactuer or formulation sample
- Develop new method for residual impurity or contaminant in product or cleaning medium
- Coordinate the daily analysis under concept of good laboratory practise, support supervisor on updating the lab SOPs to maintain good operation of QC lab,provide the training to lab technician
- Double check the test result records to ensure all of data are gengerated properly under SOPs
- Monitor the consumables inventory and chemical stock, make the request to purchase reagents, consumbles and reference standard etc
- Work as lab safety office to lead HIP topics, drill, lab housekeeping
- Report to supervisor or relevant department any unusual findings/abnomalities in lab with recommendation on corrective actions
- Maintain the SAP-QM-LIMS to ensure the system working properly
- Develop and implement maintenance plan of lab equipment to ensure the lab equipment working propely, and carry out troubleshooting as well
- Coordinate the lab auxiliary facility maintenance together with site maintenace
22
Qc Chemist Resume Examples & Samples
- Under the direction of supervision, the scientist manages change control for Analytical documents (including drafting of testing methods and specifications), Reviews methods and specifications to ensure alignment with Good Manufacturing Practices (GMPs)And other applicable worldwide regulations
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements
- In addition, the Scientist communicates and resolves comments with client areas
- B.S. and/or M.S. in an appropriate Science or Engineering discipline
- Minimum of 2 years of laboratory experience
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations
- Working experience should include performing laboratory methods, assay development and document review
- Effective communications (oral/written) and interpersonal experience along with technical writing skills
23
Qc Chemist Resume Examples & Samples
- Follow company SOPs and current Good Manufacturing Practices (cGMP) in the performance of all responsibilities
- Analyze samples in support of: instrument qualification, method validations, the raw material testing program, process validation, in-process testing requirements, R&D, stability testing, API testing, and finished product test
- Carry out method development and method validation for specified projects, under supervision
- Prepare solvent mixture, buffers, and reagents as needed for testing
- Process and analyze analytical data
- Review analytical data and test results, and compare to test specifications. Enter test results in lab reports
- Learn to troubleshoot instrument problems and work with the supervisor, laboratory chemists, and equipment manufacturer’s technical services to resolve issues
- Perform instrument maintenance, calibration, and standardizations as required
- Write standard operating procedures (SOPs) for equipment operation, methods, and general laboratory procedures as needed
- Order and maintain laboratory supplies as needed
- Experience in small molecule drug analysis
- Hands-on instrumentation experience in HPLC and/or Gas chromatography (GC)
- Instrumentation experience and expertise in HPLC (waters, empower), UV/VIS and FTIR
- Proficient in Microsoft Office including Excel and Word
- Experience with chromatography application programs
24
Senior QC Chemist Resume Examples & Samples
- Independently conducts analyses, interprets results, and develops solutions
- Develops efficient and timely project objectives. Detect and evaluate problems with analytical processes and contribute in developing methods and techniques for solutions to those problems
- Set up, troubleshoot, and make adjustments to laboratory equipment
- Detect problems in using standardized procedures
- Performs routine to complex laboratory analyses and experiments with no supervision
- Transfer, modify, and improve analytical methods
- Prepare scientific reports and documents
- Reviews other team member’s analytical data for simple tests
- Interact with internal and external clients
- Compose Standard Operating Procedures (SOPs) and GMP documents
- Provide technical advice to team members, and other Johnson Matthey Pharma Services (JMPS) departments
- Develop technical proficiency, think independently, exercise sound judgments that correspond with experience, and adhere to safe work practices
- Performs testing for the qualification of reference standards
- BS in Analytical Chemistry or equivalent with 5-7 years related experience in a pharmaceutical industry
- MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry
- Ability to write clear and concise technical reports
- Good understanding of Microsoft Office and statistical software
- Experience with common analytical techniques such as: HPLC, GC, NMR, UV, LC-MS
- Experience communicating effectively to management
25
Qc Chemist Resume Examples & Samples
- BA or BS in chemistry. Minimum two years of experience in a the lab performing chemistry related duties
- Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills are required. Familiarity with HPLC/GC analytical software
- Familiarity with GLP/GMP guidelines
- Good Communication and writing skills
- Familiarity with out-of-specification (OOS) and out-of-trend (OOT) investigation
26
Qc Chemist Resume Examples & Samples
- Responsible for the laboratory testing in accordance with company SOP’s as well as cGMP’s and GLP’s
- Maintains lab work area in a neat and ordered fashion
- Works in support of production may require weekend or off-shift work
- Has miniumal customer interaction
- Maintains data within a laboratory notebook in a neat (legible) and organized manner
- Records entries in laboratory logbooks as necessary
- Generally works in agreeable conditions. May require extended periods of standing or sitting. Requires the ability to wear a respirator or breathing apparatus
- Performs work in accordance with general and specific safety precautions
- Responsible for ensuring safety and integrity of product testing in the department
- Works in a fast paced, moderately stressful environment. Adherence to project deadlines is critical
- Consolidates all notebook pages and Chromatographic scans with the QC section of the batch record and forwards results to documentation
- Assists with the orientation of new employees
- Initiates DCR’s to correct or clarify SOP’s
27
QC Chemist / Technician Resume Examples & Samples
- Preparation of chemical test reports
- May have more responsibility in compiling, analysing and interpreting results to internal/external customers
- May perform moderately complex assignments which are non-routine which may include equipment, facilities or product design
- Conducts all business activities in accordance to the Company’s HSE policies, legal compliance requirements and Core Values
- Qualifications with a chemical/quality focus would be beneficial
- Experience in a chemical manufacturing facility
- Awareness of chemical hazards and general health, safety, environment and welfare considerations
28
Qc Chemist Resume Examples & Samples
- Ensure compliance to cGMP's in the QC laboratory
- Development of Analytical methods of new drug products and API using HPLC, GLC and UV-Vis, Dissolution, NIR Spectrophotometer
- Validation of Analytical Methods
- Calibration of laboratory equipment and instruments
- Analysis of stability samples and finished products
- 5 years of experience with a minimum of 2 years with Finished Products
- Prefers Chemists to have prior work experience with Generics manufacturing or CMO
29
Qc Chemist Resume Examples & Samples
- Applies Good Laboratory Practices to accurately record and file all raw test data, including pertinent paperwork –e.g., chromatograms, graphs, spectra and test results. Communicates results and dispositions to Production and the QA Supervisor as required. Calculates and recommends batch adjustments to Production
- Reports promptly all problems regarding procedures, equipment, products, raw materials, specifications, etc., to the QC Supervisor or designate, as well as other QC Chemists
- Associate's degree in Chemistry or a related field
- Up to 6 months of relevant work experience
- Ability to work 12 hour shifts including nights, weekends and holidays
- Bachelor's degree in Chemistry or other Science preferred
- Experience working in a quality control setting at a chemical manufacturing facility a plus
30
Qc Chemist Resume Examples & Samples
- Perform analytical testing per UT’s SOPs on raw material samples according to USP, EP and JP where applicable
- Perform analytical testing on in-process, finished product and stability samples per UT test methods and SOPs
- Prepare SOPs, set up calibration and PM programs for the applicable equipment identified for the analytical laboratory
- Plan, prepare and execute method transfer and method validation protocols as required
- Check quality control laboratory documentation to include laboratory notebooks, LIMS, SOPs, and Protocols
- Prepare appropriate reports (method transfer, method validation, and / or data summary)
- Lead investigations involving analytical out of specification results
- Troubleshoot laboratory equipment
- Proficient in Microsoft Office; Word, Excel, and Outlook
- Proficient in Waters Empower Software
- Proficient in LIMS
- Report and protocol experience preferred
- Must be detail oriented, self-motivated, organized and have the ability to prioritize work
- Must be able to work independently and as part of a multi-functional team, with the ability to handle high workloads, stressful situations and deadlines
31
Seasonal Ink Materials / QC Chemist Resume Examples & Samples
- BS degree in Chemistry, Engineering or related field with an emphasis in chemistry or materials engineering
- A 2 year degree or work experience in the ink or paint industry will be considered if candidate demonstrates a high level of technical knowledge
- Strong knowledge of chemistry, mathematics and statistics
- Knowledge in the following areas is helpful: paste ink water-based liquid inks (gravure, flexo or inkjet, etc.)
- The hours for this position are day shift Monday-Friday, with occasional work on the weekends
32
Qc Chemist Resume Examples & Samples
- Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive
- Perform and document instrumental (i.e., UV-Vis, HPLC) and wet chemistry techniques/analyses
- Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned
- Perform laboratory testing, as well as general laboratory maintenance, including in process and final product release testing and stability testing
- Bachelors Degree in chemistry, or biological sciences, preferred
- Five to Seven years related experience
- Working knowledge of standard laboratory practices and safety
- Experience with UV-Vis and HPLC highly desired
33
Qc Chemist Resume Examples & Samples
- High school diploma or equivalent
- A minimum of 60 hours of college-level work from an accredited college including a minimum of 8 hours of Chemistry or related science course(s)
- Ability to read, write and verbally communicate in the English language
- Ability to reason through operational issues as they arise and resolve or communicate to others
- Must have comprehensive knowledge of plant operations as they affect quality of product
- Must have general knowledge of calculators and computers
- A high degree of manual dexterity and accuracy required
- Preferred knowledge of all types of equipment used in the manufacturing of cement
- Knowledge of hazards associated with areas of responsibility
- Ability to perform basic math functions
- Must have a basic understanding of the plant operations
- Must have excellent work and safety record
- Must understand Lockout/Tagout procedure and safety requirements
34
QC Chemist Supervisor Resume Examples & Samples
- Supervise and assign work to QC chemist to support production. Work with Value Stream Lead to understand the priority and schedule work in lab to get testing completed on timely manner
- Review test result and ensure that all testing are performed accurately prior to approve them in LIMS system
- Review analytical methods, protocols, SOPs and other technical documents and train QC chemist on relevant procedures
- Assist with resolution of customer complaints and reviewing batch records. Investigate consumer complaints and communicate with manager and/or cross functional department as needed
- Perform elementary method analysis and development for troubleshooting purposes. Make recommendations to technical support on analytical methods
- Support continuous improvement activities within group
- Conducts and writes laboratory investigations and identify Root cause for the failure
- Ensure laboratory equipment is properly calibrated and maintained
- Test samples in accordance with established procedures and using all instrumentation required in the procedures, including AA, IR, UV-VIS
- Prepare and calibrate reagent standards
- Bachelor’s degree in Chemistry, Biochemistry or Chemical Engineering
- A minimum 5 years of laboratory experience Wet chemistry
- Proficiency with most wet chemistry techniques and gravimetric assays
- Must be able to independently evaluate results from routine analysis and identify problems and potential problems as they occur
- Prior experience as Supervisor or a very strong team leader or experience coaching/mentoring junior chemists and addressing performance and employee development in regulated QC environment is required
- Proficient in Microsoft Office, LIMS (Lab Information Management System)
- IND-LPG
35
Qc Chemist Resume Examples & Samples
- Test samples in accordance with established procedures and using all instrumentation required in the procedures, including AA, LC, GC-FID, GC-EC, GC-MS, IR, ICAP, UV-VIS
- Repair, maintain and calibrate laboratory instruments
- Review biological test results received from outside testing lab
- Assist with resolution of customer complaints and reviewing batch records
- Knowledge of biological/Microbiological testing is plus
36
Qc Chemist Resume Examples & Samples
- Performs required analytical testing on in-process and final products
- Performs USP, EP, and ACS testing on raw materials
- Testing using HPLC, FTIR, ICP-OES, UV/VIS, Liquid Scintillation, and Gamma Spectrometer
- Tracking and trending of analytical data
- Participates in validation projects requiring analytical support
- Writing and developing SOPs
- Contributes to process improvement through Lean, 5S and six sigma tools
- Assists in the stocking and supplying of the QC lab
- Performs visual inspection of finished product
- Associate degree plus 2 years working experience in Manufacturing or Laboratory or Bachelor’s
- Proficient with software applications applicable to the job
- Must be available for nights and weekends as needed
- Must have the ability to distinguish color
- Ability to lift 25lbs
- Be able to work weekends/Rotation of shifts
- Equipment experience with HPLC, ICP, UV/Vis, FT-IR
- Experience working with radioactive material including the use of gamma spectrometers, Ion
37
Qc Chemist Resume Examples & Samples
- Apply basic scientific knowledge to perform analysis and to solve simple analytical problems
- Learn and follow all Standard Operating Procedures (SOPs) and Good Manufacturing Practices. (GMPs)
- Revise SOPs, test methods, and GMP documents with guidance
- Conduct analysis and interpret results
- Transfer, modify, and improve analytical methods with guidance from experienced team members
- Prepare scientific reports with guidance from experienced team members
- Review all data regarding raw materials, intermediates, and APIs
- Perform cleaning validations and verifications
- Calibrate instruments and contribute to laboratory organization and compliance
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards
- Applies cGMP concepts in association with department specific responsibilities
- Ensures all documentation produced is in compliance with cGMP standards
- Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities
38
Qc Chemist Resume Examples & Samples
- Perform all analytical testing relating to incoming raw materials
- Perform all analytical testing relating to West Chester in-process testing
- Perform all analytical testing relating to finished goods testing
- Perform all analytical testing related to resale and toll production that is shipped from the West Chester facility
- Perform all analytical testing related to pilot plant production
- Perform all analytical testing related to reapprovals, and returned goods
- Perform all miscellaneous analytical testing as directed by West Chester’s QC Supervisor, Methods Development Chemist, and Analytical Services Manager
- Perform all necessary test method calibrations as defined in the West Chester Quality Control ISO procedures
- Perform all necessary instrument maintenance as defined in the West Chester Quality Control ISO procedures
- Perform all necessary instrument troubleshooting as defined in the West Chester Quality Control ISO procedures
- Maintain good laboratory practices in the areas of safety and cleanliness while performing the assigned analytical duties
- Reports directly to the West Chester QC Supervisor and indirectly to the Analytical Services Manager
- ¨This part time Quality Control position is designed to support West Chester production. The position includes working most, if not all weekends as well as covering shifts open due to vacation or sick. It is the duty of the part time Quality Control chemist to work safely and responsibly in all areas of the plant. It is also the responsibility of the part time Quality Control chemist to report accurate analytical results, so the West Chester facility will not ship any non-conforming product. Lastly, it is expected that the part time Quality Control chemist work with a good attitude and be a team player in decisions relating to the functioning of the laboratory
- A minimum of three years of study in a science curriculum
- Organizational and prioritization skills for efficient task completion
- Reliable decision-making skills
- Proficient in Word, Excel, Microsoft Office, Microsoft Access, and Microsoft Power Point
- Ability to use scientific logic to deal with different types of problems
- Ability to manage multiple tasks and projects concurrently and efficiently
- Ability to use personal judgment and knowledge to disseminate information
- Ability to maintain confidences within the normal course of business
- Ability to be a self-starter, manage time and work without direct supervision
- Ability to communicate established procedures in the training of personnel
- Ability to work in a consulting, advisory, and coordinating role
- Ability to communicate and work as a member of a team
- Ability to organize and prioritize work in a timely manner and react well under pressure
- Ability to interpret documents such as safety and emergency response regulations
- Ability to communicate in a professional manner, both written and orally, with individuals at all levels of the organization
- Ability to add, subtracts, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
39
Qc Chemist Resume Examples & Samples
- In a fast-paced environment, perform stability testing on solid dose pharmaceutical product using techniques such as HPLC, Dissolution, UV/VIS, and KF moisture
- Evaluate and documenting test results in accordance with company SOPs
- Troubleshoot lab equipment and perform any lab investigations in conjunction with supervisor
- Apply GMP principles throughout the process, ensuring compliance with established regulations
40
Qc Chemist Resume Examples & Samples
- Perform routine and complex sample analysis using HPLC, GC, Dissolution, USP/EP raw material testing, wet chemistry, spectrophotometric techniques, or microbiological techniques
- Performs routine and complex sample analysis to assess the conformance of raw materials, finished products, and/or stability samples per product specifications
- Performs testing and documents data, and reports results
- Demonstrates an advanced knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory
- Conduct tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal SOPs
- Ensure lab investigations are com[leted in a timely manner
- Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instruments as needed
- Communicate with clients, contractors, and regulatory agents as required
- Provide leadership and guidance to junior staff
- Work independently and seek supervision when required
- Update various GMP documents including but not limited to SOPs, QATs, HOCs, change controls, safe practices, protocols, templates and reports demonstrating strong technical writing skills
- Perform specialized maintenance and calibration of laboratory equipment (Metrology) as needed
- Perform daily maintenance and/or calibration of laboratory equipment/instruments as needed
41
QC Chemist, Raw Material Resume Examples & Samples
- Assist in the installation of laboratory equipment and qualification of laboratory equipment for intended use in QC laboratory
- Participate in the validation and transfer of internal test methods, as well as method verification of compendial methods
- Perform raw material and consumables sampling in accordance to written testing SOP’s and in accordance with local/ international regulations
- Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS) and/or Internal Validated Methods
- Support in establishing and controlling of raw material’s supplier qualification program
- Monitoring and optimization of work flows and methods/procedures, in-process control, method controls and reference’s and performs trending of on-going in process control data to pursue an on-going quality assurance program
- Participate in laboratory investigations as per local SOP and facilitate root cause analysis
- Review QC documents to ensure completeness, accuracy, consistency, and clarity and raw materials have been manufactured, tested, or inspected according to specification, local SOP and cGMPs
- Assist in optimizing test procedures to improve efficiency whenever possible
- Prepare and participate to health authority’s inspections and internal audits in QC Raw Material area
42
QC Chemist, In-process Control Resume Examples & Samples
- Support lab equipment installation and qualify/validate lab equipment for QC laboratory for operations according to cGMP standards
- Responsible in providing technical support to run and validate necessary test methods on lab equipment and later perform product testing including maintenance of product reference and assay control programs
- Ensure that priorities for testing and review are set and followed in a timely manner and involve in laboratory investigations and root cause finding
- Optimizes test procedures to improve efficiency whenever possible
- Participate to health authorities inspections and internal audits in his or her area
- Monitoring and optimization of work flows and methods/procedures, in-process control, method controls and references and perform trending of on-going in process control dat
43
Qc Chemist Resume Examples & Samples
- Test and release raw materials, mediums, and finished products using laboratory equipment
- Clean tech-ware and calibrate instruments daily by following the procedures as required
- Enter testing data and close batch tickets and purchasing orders in database
- File batch tickets and store retains
- Maintain the micro samples receiving log and submit samples for testing
- Provide support for investigation of nonconforming batches
- Perform daily housekeeping in the laboratory to ensure a safe, clean work environment
- 1-2 years quality control laboratory experience (or equivalent) in a manufacturing environment
- Possess a technical understanding of quality control tests and their relationship to the manufacturing process and/or customer processes and applications
- Good organizational skills, verbal/written communication skills and attention to detail
- Strong MS Office products knowledge and skills
- Must be able to lift up to 25lbs
44
Qc Chemist Resume Examples & Samples
- Required to work in shift & Support the in-process, finished goods sampling
- Required to do testing & reporting the in process, finished good sample
- Follow the SOP for carrying out required analysis, operating & maintaining testing equipment
- Accountable to ensure the Operation and Calibration of analytical Instruments as per laid down procedure
- Prepare all instruments Calibration Schedule, Instrument History card and servicing follow up
- Managing all documentation & data relating to Quality Control & Quality Assurance
- Ensure sample retaining & Housekeeping of the QC lab
- Handle sophisticated instrument like IR, Spectrometer & X-ray Spectrometer,
- Experience in industry related to Batch operations, compounding –preferably solid / powder material
45
Qc Chemist Resume Examples & Samples
- Demonstrated success in GMP regulated analytical environments
- Familiarity with GE TOC analyzers and FTIR with ATR (Thermo Fisher)
- Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience
46
Qc Chemist Resume Examples & Samples
- 15 %- Perform analytical tests, both automated and manual to include Wet chemistries, Flashpoint, Relative Density, Refractive Index, Color, Optical Rotation, particle size, moisture content, preparation of GC encapsulation samples and viscosity on all IFF technologies
- 25 %- Perform Data entry into various databases, reporting results and tracking (SAP, PLM, & IFFMAN). Ensure timely approval of materials in analytical and GC for all IFF technologies. Interfacing with chemists, evaluators, corporate QC on special testing and reporting results as required
- 50% - Load GC and GCMS, trouble shooting, adjustment, etc
- 10 %- Other activities as assigned by supervisor. customer complain investigation, etc
- BS Chemistry
- Strong working knowledge of Encapsulation analyses and GC analyses (trouble shooting)
- 1-2 years of work experience using QC Laboratory equipment for scientific testing
- Working experience with SAP System (or related production manufacturing software system)
- Working experience with Microsoft office - specifically Excel and Word
47
Qc Chemist Resume Examples & Samples
- Provides analytical support for production by performing GC, HPLC, and/or Wet Chemistry analysis on Raw Material, in-process and finished samples
- Supports analytical and chemical development by testing samples
- Performs wet chemistry testing: pH, LOD, MP, titrations, KF, ROI, extractions, IR, UV and physical characteristics. GC and HPLC testing will also be required
- Assists in writing of SOP’s, testing standards, protocols and reports
- Works closely with Production Shift supervisor to determine priorities, deadlines and requirements in production area. Responsibilities in production area may include: witness DEA transactions, swabbing, witness charging, documentation evaluation and any other Quality or Production functions deemed necessary
- Calibrates production pH meter
- Assists in training of lab personnel on instrumentation, methods, and cGMP
- An BS/BA Degree in chemistry or related science with 3-6 years direct QC lab experience
- 4-6 years’ operating HPLC, and GC in a cGMP regulated QC laboratory
- Strong working knowledge of operating and troubleshooting GC and HPLC, and utilizing Totalchrom software
- Knowledge of cGMP is a plus
48
Qc Chemist Resume Examples & Samples
- Knowledge and understanding of Stop Orders, Concessions, ESD, Calibration, Preventative Maintenance, Material Identification & Segregation, documentation configuration control practices; documentation & disposition of non-conforming material, and Good Documentation Practices requirements, as associated with this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Associate degree plus 2 years working experience in Manufacturing or Laboratory or Bachelor’s degree
- Ability to speak, understand, read, and write in local language
- Waters Empower Experience or similar software
- Experience working with radioactive material including the use of gamma spectrometers, Ion Chambers and liquid scintillation analyzers
- Visual inspection experience
- Working knowledge of USP
- Experience in a FDA regulated QC environment
- Background in Math or Chemistry
49
Chemist, QC Chemist Resume Examples & Samples
- 0-2 year experience in the application of laboratory techniques in a manufacturing QC environment
- Demonstrate proficiency in the use of basic laboratory techniques and equipment
- Able to follow detailed procedures and have good documentation skills
- Ability to work in a team environment, make decision of a limited scope which is subject to review
- Good organization, communication, multi-tasking and computer skills
- Basic math skills in a science environment
50
QC Chemist Intern Resume Examples & Samples
- Perform routine physical testing on clinical and stability samples such as pH, viscosity, and osmolality
- Prepare solvents and samples for HPLC analysis and operate the HPLC for analysis of clinical, stability, and raw material samples
- Run routine raw material testing as necessary
- All work and documentation will be performed per cGMP and InSite Vision’s procedures
- Help maintain the labs in a clean, organized, and safe condition
- Assist QA or QC Microbiology as trained and directed
- Requires coursework in Chemistry at the High School level, or equivalent
- Must possess excellent analytical skills and laboratory techniques and the ability to multi-task and work in time sensitive situations
- Must possess excellent interpersonal, communication (oral and written), and organizational skills
- Ability to anticipate and resolve issues and work effectively in a team environment
- Must possess ability to navigate computer systems with little assistance. Basic knowledge in the use and application of the Microsoft Office (Excel, PowerPoint, and Word) is required
51
Shift QC Chemist Mon-thur Resume Examples & Samples
- Perform physical and chemical testing of non-pesticide and pesticide products packaged for consumer use
- Maintain Technical Quality laboratory in compliance with cGMP and GLP regulations
- Calibrate, maintain, operate, and troubleshoot analytical and laboratory equipment (GC, HPLC, FTIR, and other general lab instruments)
- Prepare solutions for treating consumer packaged products for production, quality and shipment
- Work on project developments and stability studies
- Monitor incoming ingredient quality control
- Set up equipment used in the Research and Development Pilot Lab for experimental and process development studies
- Assist in the scale up and transfer of R&D products to commercial manufacturing sites
- Assist in the preparation and reconciliation of scientific paperwork
- Support (set-up, tear down, maintenance) for cGMP and Non-GMP Laboratory Equipment
- Support Scientists and Technicians in Batching Process Equipment Setup and Manufacture
- Support Engineering on New Equipment Qualifications
- 3+ yrs of laboratory experience required
52
Qc Chemist Resume Examples & Samples
- Perform analytical testing per United Therapeutics (UT) SOPs on raw material samples according to USP, EP and JP where applicable
- Perform analytical testing on in process, finished product and stability samples per UT test methods and SOPs
- Execute method transfer and method validation protocols
- Check quality control technicians’ documentation
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Working knowledge of HPLC, Dissolution, GC and other analytical techniques
- Must be detail oriented, self motivated, organized and have the ability to prioritize work
- Ability to work independently and as part of a multi-functional team
- Ability to handle high workloads, stressful situations and deadlines
53
QA / QC Chemist Resume Examples & Samples
- Support lab functions by maintaining instruments (calibrations, standards, troubleshooting)
- Interface with suppliers for instrument maintenance contracts, repairs, and calibrations
- Interface with external customers to assist with product issues
- New method development, data gathering, statistical evaluations, etc
- Plant support by troubleshooting and performing analyses and reporting results effectively
- Perform safety, quality and ISO audits
- Bachelor’s of Science in Chemistry or Bio-Chemistry required
- 5 or more years’ experience in analytical or polymer chemistry a plus
- Familiarity with LIMS, databases, Gas Chromatography, XRF, and titrations a plus
- Understanding Design of Experiments (DOE) preferred
- Six Sigma certified preferred
- Knowledge of ISO 9001 and IATF 16949 requirements preferred
- Must be able to demonstrate strong problem-solving skills
- Must possess strong interpersonal and teamwork skills – ability to work with customers in cross functional groups
- LI-KC1
54
QC Chemist / Documentation Specialist Fremont Resume Examples & Samples
- Writes and edits SOPs relating to Quality Control testing/process instructions, policies, and procedures
- Independently completes writing assignments according to set standards regarding order, clarity, style, and terminology
- Reviews published materials and recommend revisions for changes in scope, format, and content. Maintains records and files of work and revisions
- Work with QC Scientists and Supervisors on the design, layout, review editing and revision of procedures, and other testing documentation
- Organizes large amounts of technical information utilizing Advanced MS Word and Excel functions, as well as managing many technical documents simultaneously
- Participate in cross functional project teams, as required
- Bachelor’s degree or equivalent experience
- Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint)
- Minimum of 2 years work related experience using a Document Management System
- Proficient with configuration change management priniciples and working knowledge of following and tracking record retention schedules
- Proficient with 55+ wpm minimum typing speed
- Knowledge of ISO 13485, FDA QSRs and GMP is preferred
- Ability to work in high-pressured deadline oriented environment
- Good skills at alpha and numeric sequencing & filing
- Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy
- Must have excellent customer service and listening skills
- Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data
- Able to sit, stand and/or use keyboard for long periods of time
- Must have the skills to work as a strong contributor in a team effort
55
Qc Chemist Resume Examples & Samples
- Test raw materials using HPLC, GC, KF and various wet chemical methods meeting stringent time lines and schedules
- Enter data into LIMS (Laboratory Information Management System)
- Accurately document all tests/test materials/equipment used and all results obtained
- Work in accordance with approved methods, SOPs, and cGMPs/GLPs, while performing tests
56
Qc Chemist Resume Examples & Samples
- Science Degree in Chemistry or equivalent with at least 2 years of laboratory experience
- Manages the chemistry laboratory activities to assure timely availability and accuracy of results
- Reviews and approves all required chemistry testings for utilities, raw materials, manufacturing processes and products and ensures that the tests are analyzed in accordance with corporate, regulatory and external agency regulations
- Enforces all laboratory policies and practices, and ensure that all in-use procedures are current and compliant
- Maintains all safety and security policies and practices
- Supports equipment/software/method validation and performs (re)validation when necessary
- Monitor results and issues corrective actions when appropriate
- Provides support and technical expertise to ensure that manufactured products meet applicable regulatory standards and guidelines with respect to Quality control operations
- Ensures expenditures are within budget
- Keeps up-to-date on the regulations concerning biopharmaceutical QC activities
- Participate in investigation of non-conformities (deviations and exceptions)
- Problem solving
- Identifies and reports problems in QC. Solves problems and implements corrective actions
- Presents in a timely manner major issues to the management with strategies on their resolution
57
Qc Chemist Resume Examples & Samples
- Analyze in process samples of ETP plant
- Analyze treated Effluent samples
- Analyze water samples
- Analyze outlet sample for consent parameters
- Calibration of lab instruments
- Documentation of lab results
- Experience in NABL accredited lab
- Ensure EHS compliance
- Ensure best house keeping
58
Qc Chemist Resume Examples & Samples
- Responsible for calibrating and testing various analytical instruments to ensure that test results are reliable
- Prepares appropriate documentation for test results so that trends can be identified and analyzed
- Collaborates with S & T to perform and establish specific quality standards and specifications for chemically or biologically modified products
- Ensures compliance with federal, state, and local regulatory requirements
- May investigate customer complaints and provide management with test results information
- Calibration, operation and results interpretation of HPLC, GC, FTIR. Perform wet chemical analysis and Titration, Percent of Non-Volatile Materials, Refractive Index, Karl Fisher Moisture, Viscosity as well as other miscellaneous test methods
- Performs special assignments upon request
- Must be available to work all shifts and weekends as required
59
Qc Chemist Resume Examples & Samples
- Ensure that the Quality System of DIQCL is properly implemented and adhered to according to at all times
- Ensure that all quality and technical operations are in compliance with ISO 17025 DuPont standard and other compliance obligation
- Review the LQM, LPM, LWIM and all other associated documents every 3 years
- Ensure that internal quality audits conducted at least once a year
- Ensure that all staff are committed to quality and continuous improvement and maintain discipline among staff within the laboratory
- Ensure all staff are properly trained and able to perform their jobs professionally without any undue influence from any quarter
- Document and data control according to ISO 17025, DuPont lab standards and other compliance obligation
- Plan and implement all quality assurance programmes and activities such as ISO 9001, GMP and HACCP, EMS effectively
- Shall adhere to all company’s policies, rules and regulations and committed to company’s quality and continuous improvement programs such as MS ISO 9001, GMP, HACCP, RSPO, BRC, EMS
- Ensure implementation of Environmental Monitoring Program on monthly basis and escalate to QA Manager when deviation arise
- Handles customer requirement eg, lab test, customer complaint investigation responds, pre shipment sample, lab blend and other internal customer request
- Ensure smooth operation during the working hours of the laboratory
- Any other tasks or projects assigned by the superior
60
Qc Chemist Resume Examples & Samples
- Maintains current, complete, legible notebooks and laboratory records in compliance with good scientific and regulatory practices. Maintains adequate inventories of reagents, glassware, and other supplies
- Writes and executes laboratory investigations for known laboratory errors and OOS results using Trackwise and/or other QC procedures
- Utilizes Personal Protective Equipment (PPE) as necessary
- BS/BA degree preferred; ideally in a scientific or technical discipline and/or relevant laboratory experience within a Pharmaceutical Quality Control Laboratory
- Basic understanding of cGMPs and regulatory requirements as they relate to laboratory practices and manufacturing processes
- Ability to prioritize workload and manage multiple and varied tasks with enthusiasm
61
Qc Chemist Resume Examples & Samples
- Analyze and / or test under cGMP, raw materials, intermediates and finished products by applying validated or compendia methods
- Release testing of products per current compendia, regulatory and corporate quality systems, and principles
- Performs analysis in the laboratory with minimal supervision
- Prepares standards, mobile phases, and reagents
- Calibrates and monitors laboratory equipment (HPLC, GC, ICP, etc.)
- Analyzes raw materials, intermediates, stability samples and finished products for required tests by various analytical and instrumental methods
- Performs calculations, collects and prepares data for evaluation
- Keeps supervisor informed of work status
- Investigation of OOS results under guidance of senior staff
- Maintains good documentation practices
- Work according to SOP’s and Specification sheets
- Demonstrate the ability to learn and perform lab specific analytical methods
- Complete analysis on raw materials and finished products within an agreed upon turnaround time
- Ensures SOP’s and specifications are up to date and in compliance with current Compendia and updates them if required
- Performs and documents all work associated in adherence with cGMP guidelines
- AS/BS Chemistry
- 1-3 years lab experience
- Exp. w/ quality control techniques and methods. (raw material testing, HPLC, GC)
- GMP
62
Qc Chemist Resume Examples & Samples
- Perform analytical and physical testing on in-process, finished product and stability samples
- Maintain analytical methods in the laboratory in a state of validation
- Assist in addressing laboratory investigations within specified time frame
- Perform accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines
- Participates in laboratory root cause investigations and quality system improvement initiates by executing well defined protocols and procedures
- Shares technical information and best practice within the group
- Conduct studies to validate methods, develop methods, evaluate new technologies. Sample Analysis
- Coordination of method transfers and co-validations
- Qualifying, calibrating, and maintaining analytical instrumentation
