Qc Scientist Resume Samples

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J Ebert

Jasper

Ebert

6238 McKenzie Fork

Dallas

+1 (555) 115 3658

6238 McKenzie Fork

Dallas

Phone

p +1 (555) 115 3658

Experience Experience

Chicago, IL

Qc Scientist

Chicago, IL

Carroll, Reichert and Stoltenberg

Chicago, IL

Qc Scientist

Continuously drive to improve processes for improved performance
Assist in basic technical writing such as specifications, laboratory work sheets, standard operating procedures, and technical reports
Performs assay development/validation for QC Chemistry group
Perform assay development/validation for QC Chemistry group
Design and perform experiments to develop, validate, revise and transfer new analytical/microbiological methods including automated and robotic methods
70% Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
To have working knowledge of the following Quality system: LIMS; Entering and checking of results

Boston, MA

Senior QC Scientist

Boston, MA

Parker-Satterfield

Boston, MA

Senior QC Scientist

55% Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
Perform bioassay development/validation for QC. Troubleshoot existing bioassays in commercial and clinical portfolio
55%: Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
10%: Evaluation of new technologies
Review new test procedures and assays
Participate in technical troubleshooting and problem investigation

present

Houston, TX

Senior QC Scientist & Technical Lead

Houston, TX

Hyatt-Schuppe

present

Houston, TX

Senior QC Scientist & Technical Lead

present

Work with QC, QA, Supply Chain, Analytical Development, Regulatory Affairs
Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers
Project Management
Support continuous improvement activities related to Quality Control and compliance
Lead management of the document change requests for method SOPs
Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives
Creates and presents trending and metrics reports on deviations and corrective actions

Education Education

Bachelor’s Degree in Biology

University of Arizona

Bachelor’s Degree in Biology

Skills Skills

Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Good time management and attention to detail
Excellent written communication skills (SOPs, professional reports, emails)
Strong analytical ability and associated problem solving
Excellent verbal communication skills
Knowledge of synthetic chemistry
Ability to keep order of multiple projects/tasks
Excellent Communication skills, both verbal & written
Familiarity with Quality guidance documents (ICH, CFR, USP, general guidance)

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15 Qc Scientist resume templates

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Senior QC Scientist Resume Examples & Samples

55% Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
30% Organization support and project team participation; may include managing people
15% Evaluation of new technologies

Qc Scientist Resume Examples & Samples

70%
BA/BS in relevant scientific discipline with a minimum of 8 years relevant industry experience
Technical expert in one or more analytical technologies
Proactive at keeping current with literature and latest technologies
Conducts work in compliance with cGMPs, safety and regulatory requirements

Qc Scientist Resume Examples & Samples

70% Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
20% Organization support and project team participation; may include managing people
10% Evaluation of new technologies

Qc Scientist Hplc Resume Examples & Samples

70%: Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
20%: Organization support and project team participation; may include managing people
10%: Evaluation of new technologies
Ability to walk and stand for periods of time

Senior QC Scientist Resume Examples & Samples

55%: Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
30%: Organization support and project team participation; may include managing people
Ability to work around chemicals (if working around the laboratories)

Senior QC Scientist & Technical Lead Resume Examples & Samples

QC oversight and effective management of Shire Contract test laboratories utilized from release and ongoing stability testing
Development of strategic short term and long term approaches to release and stability method performance and improvements, analytical support for process improvements, product comparability assessments
Interpretation of data trends for both release and stability, life cycle of methods and other technical support as required
Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests and improvement initiatives
Lead investigator with strong understanding of compliance and cGMP’s, strong scientific judgment and leadership in decision making
Participate in cross functional teams to close investigations, determination of root cause and implementation of appropriate CAPAs
Create and presents trending and metrics reports on deviations and corrective actions
Lead management of the document change requests for method SOPs
Provide representation to tech transfer and CMC teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers
Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies
QC oversight of contract testing laboratories
Investigations of process deviations in house
Author and review protocols for QC
Support regulatory inspections and filings related to general analytical methodologies
Work with QC, QA, Supply Chain, Analytical Development, Regulatory Affairs
Support continuous improvement activities related to Quality Control and compliance
MSc or BSc. in Chemistry, Biology or other related fields with
Experience dealing with contract testing organizations is preferred
Team leadership
Good knowledge of statistical techniques in the use of problem solving/data analysis
Ability to demonstrate standards of leadership – managing complexity/Innovations/Customer Focus, Flexible Team Player, Good influencing skills
Experience of Technology Transfer of analytical methods
Regulatory filings and inspections
Strong knowledge of EU cGMPs and FDA guidelines

Qc Scientist Resume Examples & Samples

Oversight of Contract testing laboratories, data analysis, data trending, project and testing coordination, support of product specification management, COA generation, material specification creation, document revisions, compilation of department specific KPIs, supporting site integration of existing processes and procedures and rationalizing other QC practices
Regulatory and/or inspection support, method projects activities, initiating/completing quality systems, supporting the internal and external audit programme
Evaluation of new technologies and other QC activities as required (ex. Continuous improvement activities)

Qc Scientist Resume Examples & Samples

Develop and implement comprehensive Assay Maintenance programs to support biological/molecular assays
Support analytical method validation and stability programs by writing validation protocols and reports, conducting qualification and/or validation experiments, performing ongoing assay maintenance and reagent stability testing, and developing assay trending programs
Work directly with the Process Analytical Development group to select and characterize appropriate reagents for GMP-compliant QC testing, including sourcing and development of comparability testing protocols of off the shelf equivalents and secondary suppliers
Design reagent qualification and maintenance programs, including study design, acceptance criteria, data analysis, frequency of testing, tracking and reporting results, management of reagent inventory, and qualification of new lots
Implement and qualify strategies for optimization of shelf life and expiration dating of critical assay reagents including stability studies, storage and use controls, and alternate packaging schemes
Assist in the evaluation and implementation of new technologies associated with microbial and safety assays including development of programs necessary to implement and validate new technologies to replace classic compendia methods such as sterility, endotoxin and mycoplasma testing
Maintain analytical equipment under GMP and contribute to equipment validation. Write analytical method and equipment SOPs
Assist in troubleshooting and evaluation of biological assay test methods performed and data generated by contract laboratories
BS/MS in relevant scientific discipline and 10+ years experience (including 2+ years in a QC laboratory setting) in GMP operations, or equivalent combination of education and experience
Strong knowledge of GMP compliance and Quality Control
Experience in writing protocols, SOPs, reports, and other controlled documents
Technical proficiency and experience with biological assay methodology such as cell based assays, flow cytometry, ELISA and statistics is required
Strong understanding of analytical method lifecycle, including assay qualification, validation, transfer, and maintenance Proficiency in PCR and other molecular biology methods, strongly preferred
Background in Protein Biologics or Cell Therapy Manufacturing, strongly preferred
Understanding of FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of therapeutic biologics and cellular therapy products
Experience in creating and/or implementing assay validation and/or maintenance programs for quality control
Background in compendia microbiological methods and QC safety testing
Experience with alternate microbiological detection and identification methods such as FTIR, flow cytometry, PCR or mass spec, strongly preferred
Understanding of biological product development and commercialization including Quality Control programs required to support GMP manufacturing, testing, and distribution of product

Senior QC Scientist Resume Examples & Samples

Perform bioassay development/validation for QC. Troubleshoot existing bioassays in commercial and clinical portfolio
Participate in technical troubleshooting and problem investigation
Participate in training program for analysts
Previous supervisory experience required
Previous cell culture and tissue culture experience required

Qc Scientist Resume Examples & Samples

Performs assay development/validation for QC Chemistry group
May evaluate and bring in new methodologies/techniques when needed
Facilitate assay transfer from R&D and to business partners
Organize analytical assay transfer internally and externally
Set product specifications
Participates in technical troubleshooting and problem investigation
Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
Participates in training programs for analysts
Requires Ph.D in Biochemistry, Chemistry, Biology or related field with 3+ years of relevant experience preferably in the pharmaceutical or biotechnology industries

Qc Scientist Resume Examples & Samples

BS in science (chemistry or biology focus preferred)
Experience reviewing analytical data
Knowledge of synthetic chemistry
Ability to keep order of multiple projects/tasks
Familiarity with regulatory filings like IND and BLA
Familiarity with Quality guidance documents (ICH, CFR, USP, general guidance)
Excellent verbal communication skills
Excellent written communication skills (SOPs, professional reports, emails)
Broad experience with Microsoft Office products
Stability study experience (drafting/reviewing/managing)
Experience testing in a pharmaceutical QC lab (small molecule testing)

Senior QC Scientist & Technical Lead Resume Examples & Samples

QC oversight and effective management of Shire Contract test laboratories utilized from release and on-going stability testing
Development of strategic short-term and long-term approaches to release and stability method performance and improvements, analytical support for process improvements, product comparability assessments
Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives
Lead investigator with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making
Participate in cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs
Creates and presents trending and metrics reports on deviations and corrective actions
Lead management of the document change requests for method SOPs. Provide representation to tech transfer and CMC teams as needed, review
QC management and oversight of contract testing laboratories
Ph.D. in Chemistry, Biology or other related fields with >4 years of relevant or Industrial experience/MSc/PGD with >6 years of relevant experience
Good knowledge of statistical techniques in the use of problem solving data analysis
Ability to demonstrate standards of leadership - managing complexity/ innovations
Customer Focus Flexible Team Player Good influential skills
Degree in Chemistry or Biological sciences. High level degree is preferred
This position requires excellent organizational and communication skills,
Knowledge and understanding of regulatory requirements and industry practices is required
The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets
Teamwork and collaboration skills are integral to the position
Living the values at Shire is a basic expectation for all Shire employees. Shire expects all employees for live the BRAVE values
Build on Integrity: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment
Risk a “Risk”: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference
Act on the Needs of Patients: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with
Vie to Be Better than Yesterday: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress every day to avoid the complacency that prior success may bring
Exemplify Trust & Openness: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges

Qc Scientist Resume Examples & Samples

Perform assay development/validation for QC Chemistry group
Review new test procedures and assays
Participate in training programs for analysts
Ability to work independently or on a team
Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
Requires Ph.D in Biochemistry, Chemistry, Biology or related field and 4+ years of experience; cGMP experience is desirable. Supervisory experience is required

Qc Scientist Resume Examples & Samples

Develop, revise and author complex, explicit documentation, i.e. new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics
Participate in determining objectives of assignment
Solve assay/analytically-related process problems
Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process
Participate in coordination of completion of specific project tasks with other departments
Train and manage analysts and scientists as necessary
Work independently with minimal supervision and direction
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures
Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products
Bachelor’s degree or equivalent and 10+ years of experience OR Master’s degree or equivalent and 5+ years of experience OR PhD or equivalent and 1+ years of experience
Strong computer skills in relevant applications

Qc Scientist Resume Examples & Samples

Document writing for transfers/validations/investigations
Perform assay work for transfers/validations/investigations
Leads set up and verification of electronic equipment/templates/forms for transfers/validations
Attending project team meetings
Independently drive projects to on-time completion
May lead OE initiatives, process improvements, assist in the hiring of staff
Experience in use and troubleshooting of FACS instrument
Experience in mammalian cell culture
Experience troubleshooting and executing bioassays
Experience troubleshooting and executing ELISAs
Experience in HPLC and/or Capillary Electrophoresis work is a bonus
Experience in deviation/investigation writing using TrackWise or similar management system
Has previously been a successful trainer to junior staff members

Qc Scientist, Nd Shift Resume Examples & Samples

The qualified candidate will have a minimum of a Bachelor Degree required. Degree in Chemistry or related scientific discipline preferred
A minimum of 6 months of related experience is required
Pharmaceutical or consumer healthcare industry experience is preferred
Knowledge of lab instrumentation/equipment is required
Experience with pH meter, viscometer, FTIR, HPLC and GC is preferred
Knowledge of Compendia such as USP, NF, EP and FCC is required
Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) are required
This position is located in Lititz, PA and may require up to 5% travel based upon business needs.Quality Control

Qc Scientist Resume Examples & Samples

Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project)
An in-depth understanding of health and safety policies, Company policies and procedures, and an in-depth understanding of the GxPs
The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc
Industry experience in a relevant field

Characterisation & QC Scientist Resume Examples & Samples

Degree or postgraduate degree in a scientific or engineering discipline
Significant experience developing methods for the physical, structural and electrochemical characterisation of materials and devices
Has used analytical skills to develop a product/idea/process from concept to technology demonstration
Experience of Thin film deposition methods, Vacuum (UHV & HV) engineering, Vacuum system assembly, design and maintenance
Experience of working in Hazardous& complex environments, (e.g. dry / explosive / particulate / vapour)
Proficient in MS Office packages including Excel
Knowledge of Statistical process/measurement control and validation

Qc Scientist Resume Examples & Samples

Utilize specialized technical knowledge and skills to make detailed observations and analyze data within operating parameters. Assist with troubleshooting for specific processes or activities as assigned
Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions
Identify opportunities to optimize existing manufacturing processes and ensure compliance with regulatory requirements
Advise the team lead/manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials
Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and 5+ years of experience in a manufacturing or research laboratory -OR-
Master’s degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and 3+ years of experience in a manufacturing or research laboratory
Experience in the use of scientific laboratory techniques, equipment and materials
Ability to work independently/in a group setting with direct supervision
Works on assignments that are moderately complex in nature where judgment is required in identifying problems and contributing to solutions

QC Scientist Elisa, Qpcr, Sds-page, IEF Resume Examples & Samples

Analytical experience with ELISA, qPCR, SDS-PAGE, IEF and/or cell culture
Perform execution of technical transfer
Instrumentation verification and preventative maintenance

Qc Scientist Resume Examples & Samples

To have working knowledge and be able to conduct Finished Product QC release testing as required by the role with daily supervision as required using techniques such as Balances, pH meter, UV, Karl Fisher, FT-IR, TLC, Dissolution and HPLC (to include degradation analysis)
To be able to generate a simple test plan for a validation project
To be able to write a stability report based on the protocol and test results generated
To have working knowledge of the following Quality system: LIMS; Entering and checking of results
Qumas; printing documents, and creation of basic CR’s
To understand and correctly implement written instructions with below the average number of method deviations
To perform analytical work with average testing volumes/output whilst generating data with no more than the average laboratory notebook Right First Time error rate and no less than the average analytical Right First Time as a result of human error
To manage day to day tasks with minimal supervision/guidance
Be able to correctly interpret product tracking sheets
Identify correct specifications and methods for testing, including stability and validation protocols
Complete allocated task in time frame provided and have awareness of the wider team and support peers as required
May plan own workload in conjunction with Senior Scientists
Be able to identify laboratory out of specification and out of trend results
Perform preliminary investigations of basic deviations and complete investigation FM022 forms
Complete laboratory rota’s as required
Understand and implement lab ordering processes via VMI and Kanban systems
Maintain personal and communal laboratory areas in line with 5S principles

Qc Scientist Resume Examples & Samples

Participate in training of less experienced staff on new technology
Develop and author complex and explicit documentation for new and current procedures, validation protocols and technical reports
Identifies potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process
Solves assay/process problems
Identify deviations from QC methods and develop appropriate CAPAs
Recommend laboratory and equipment-related improvements
Work effectively with others to achieve shared goals and meet timelines
Interact with internal and external personnel on technical matters requiring
Proficient in Microsoft Office; Empower data system and lab based data management systems
Ability to present technical data
Ability to work independently on scientific projects
Familiarity with USP and global compendia regulations
Scientific technical writing ability including authoring and revising SOPs, validation protocols and technical reports
Experience troubleshooting of assay and equipment issues
Supervisory experience in QC laboratory setting

Qc Scientist Resume Examples & Samples

Bachelors Degree with Microbiology Coursework, OR Associates Degree + 2 years pharmaceutical or GMP regulated microbiology lab experience, OR High School Diploma + 4 years relevant pharmaceutical or GMP regulated microbiology lab experience
Experience of providing QC testing support to at least one value stream
Developing knowledge and application of the Quality Management System (QMS)
Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations
Develop/design lab studies and protocols to be
Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy and various instrumentation (e.g, HPLC, Vitek, GC, UV, microscope, gram stainer, robotics) while adhering to cGMP and established

Qc Scientist Resume Examples & Samples

Perform Quality Control testing for in-process, release, and stability in a cGMP environment
Perform other key activities such as data review to Ensure laboratory cGMP compliance is maintained
Assist with laboratory investigations, writing procedures and technical document

Qc Scientist Resume Examples & Samples

We are looking for someone with strong project management experience within a relevant industry
The ability to get things done by influencing others (both internal and external)
An up to date knowledge of regulatory guidelines is desirable
Knowledge of drug development process
Commercial awareness, interpersonal and negotiating skills
Learn and maintain knowledge of process excellence processes, tools and activities

Qc Scientist Resume Examples & Samples

Conduct in-process and final product testing following Standard Operating Procedures
Responsible for assuring that products are tested to meet the highest quality standards as determined by performance specifications
Responsible for ensuring that QC tasks are completed according to: schedule, company policies, procedures and test methods
Effectively implement and maintain the company's standard operating procedures for Quality Control
Understands test results and pursues clarification of unusual results. Develops and uses system for anticipating and recognizing errors. Resolves discrepancies and reports results
Adheres to good documentation practices to ensure data integrity and traceability

Qc Scientist Resume Examples & Samples

Performs laboratory testing of raw materials, materials in-process and finished products using classical wet methods and validated instrumental methods of analysis, in accordance with company test methods
Assures that instruments used in analytical methods are calibrated and performing properly
Performs investigational testing of complaint samples using appropriate analytical methods
Performs standardization of solutions and instruments as required and records results in official logs
Records all results of testing in logbooks, directly on report forms or into the laboratory computer system using proper documentation. Maintains records in accordance with cGMP
Embraces and demonstrates the company’s values on an on-going basis
Communicates potential problems and issues to the Team Leader in a timely manner
Review unusual assay results with the Team Leader to determine the method of solution, suggesting appropriate alternative tests
Initiates and completes analytical laboratory investigations in a timely manner
Acquires, maintains and applies current professional knowledge and skills associated with the job
Demonstrates competent computer use (entry/retrieval)
Orders laboratory supplies as needed
Adheres to regulatory, company and departmental requirements
Experience with review of laboratory documentation for compliance to applicable standard operating procedures and guidelines
Knowledge Validate/Approve results in LIMS
Bachelor's Degree is required. Degree in Chemistry or related is preferred
A minimum of 3 years of analytical laboratory experience within the pharmaceutical or consumer healthcare industry is required
Experience with lab instrumentation/equipment such as pH, viscometer, and FTIR is preferred
Hands on set-up and troubleshooting experience with HPLC and GC required
Experience with sample preparation required
Experience with a chromatographic data acquisition system required
Experience with Compendia USP, NF, EP and/or FCC preferred
Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) required
Up to 5% travel is required based upon business needs.8810170426

Qc Scientist Resume Examples & Samples

70%:Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
Technical expert in one or more analytical technologies such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays
Ability to troubleshoot method performance and propose corrections is essential
Fluency in English required and German is desirable
Excellent communication, interpersonal and organizational skills in a cross-cultural environment
Project management experience would be a plus
Self-driven, highly motivated, cooperative and proactive
Organizational and problem solving skills
Six sigma Greenbelt or Blackbelt would be a plus

QC Scientist, Analytical Lab Resume Examples & Samples

Must be qualified to perform multiple analytical tests including wet chemistry techniques
Routinely tests raw materials and finished products for conformity to specification using standard operating procedures
Determines the acceptability of a product or raw material based on test data and test specifications
Confers with team leader on various problems and works in conjunction to develop or improve methodology
Communicates problems and potential problems as well as proposes solutions to the Team Leader in a timely manner
Acquires, maintains and applies current professional knowledge and skills appropriate to the job
Performs other duties as assigned and directed
A minimum of a Bachelor’s Degree in Chemistry or related sciences is required
A minimum of five years of experience in analytical chemistry is required, preferably in the pharmaceutical or consumer healthcare industry, including analytical instrumentation experience and knowledge of GMPs
Experience with maintenance and troubleshooting instrumentation is required
Experience with sample preparation (high volume, technique driven) is required
Experience with a chromatographic data acquisition system is required
Experience with Compendia such as USP, NF, EP and FCC is required
Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) is required
Experience writing investigations is required

Qc Scientist Resume Examples & Samples

Receive assays from biochemistry development group and implement them in the QC laboratory. This will involve validation and transfer activities
May involved with assay development/validation for biochemistry assays
Reviews new test procedures and biochemistry methods
May evaluate and bring in new methodologies and technologies for biochemistry as needed
Facilitate assay transfer to external contract labs and business partners
Participates in technical troubleshooting and problem investigations
Review method development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
Author technical protocols and technical reports for studies not limited to method improvements, method validation, and investigations
Work with relevant subject matter experts from IOPS and Tarrytown as well as laboratory management to determine best practices for biochemistry assay design and execution
Support investigations and the associated documentation and review
Ability to organize and maintain data or information
Ability to learn through observation and hands on experience
Ability to maintain integrity and honesty at all times
Ability to work independently or as part of a team
Ability to communicate with transparency
Continuously drive to improve processes for improved performance
Demonstrate respectful behavior at all times
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Requires Ph.D in Biochemistry, Chemistry, Biology or related field, and 0-2 years of industrial experience preferably in the pharmaceutical or biotechnology sector
Experience in a cGMP/cGLP pharmaceutical environment strongly preferred
Experience with molecular biology techniques such as ELISA and PCR

Qc Scientist Resume Examples & Samples

BS(minimum) in Biological Science or related technical field
At minimum 1-3 years of related experience or equivalent combination of education & industry experience
Experience with the instrumentation and assays which will be performed in this job. See description of those techniques above
Extensive knowledge of QC testing principles and procedures, as applicable to focus of position
Extensive exposure to cGMP environment
Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures
Strong interpersonal and communications skills; written and oral
Understanding of applicable regulatory requirements
Laboratory documentation review and revision experience

Qc Scientist Resume Examples & Samples

Knowledge of company products and quality impact as it relates to those products
Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Ensuring
Understanding of products, data and statistical tools to enable the construction of through life specifications and shelf-life specifications
Experience of working in teams to improve processes or resolve problems using OE tools
Full understanding of the requirements and application of GMP principles in a laboratory environment
Effective verbal and written communication on an individual and group basis targeted to appropriately
Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods and various instrumentation (e.g., HPLC, Vitek, GC, UV, microscope, gram stainer, robotics) while adhering to cGMP and established policy
Assist in analytical/microbiological method development, validation, revision and transfer including

Qc Scientist Resume Examples & Samples

Performs assay development/validation for QC Chemistry or Biochemistry groups
Evaluates and bring in new methodologies/techniques when needed
Lead technical troubleshooting and problem investigation
Represent QC in project teams and provide Quality input across functional areas
Oversee Contract Laboratory testing
Position requires strong technical and troubleshooting skills in combination with strong communication skills in order to meet QC objectives
Requires approximately 30 to 40% of direct time in the laboratory
Write and review CMC sections for regulatory submissions
Excellent Communication skills, both verbal & written
Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage
Adaptable and flexible, willing to travel when needed
Collaboration and team work. Maintains the highest standards of ethical behaviour
Results and performance driven
Strong analytical ability and associated problem solving
Good time management and attention to detail
Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint

Associate QC Scientist Resume Examples & Samples

Support raw material qualifications, method transfers
Support validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis)
Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications
Perform routine/non-routine data analysis calculations
Document analytical data under cGMP and corporate guidelines
Participate and resolve laboratory investigations of unexpected analytical results
Write/review SOPs, test methods, material specifications, validation protocols and reports
Support cGMP laboratory initiatives following laboratory SOPs
BS or MS degree in Chemistry, Biochemistry or related
6 years experience with a Bachelors or 4 years with a Masters Experience with raw material qualifications, assays UV VIS, SDS Page, wet chemistry, GC and HPLC preferred
Support raw material qualifications, method transfers and validation of assays