Quality Scientist Resume Samples
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Quality Scientist Resume Samples
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BL
B Lakin
Buster
Lakin
7146 McDermott Tunnel
New York
NY
+1 (555) 554 1452
7146 McDermott Tunnel
New York
NY
Phone
p
+1 (555) 554 1452
Experience
Experience
Phoenix, AZ
Quality Scientist
Phoenix, AZ
Haley, Kub and Rodriguez
Phoenix, AZ
Quality Scientist
- Write investigations when necessary utilizing Method 1 and the DMAIC process of their own work and assist in the investigations of work done by others
- Work independently and exercise good time management for assigned workload (High level of productivity)
- Provide basic project support
- Effectively work in a team environment and communicate with multiple departments
- Execute all written procedures
- Support the Quality Assurance Specialist and Hygiene Manager
- Understand the performance of the assays responsible and support all critical reagents with guidance
Philadelphia, PA
Quality Control Scientist
Philadelphia, PA
Zboncak LLC
Philadelphia, PA
Quality Control Scientist
- Ensuring testing is performed in accordance with standard operating procedures, guaranteeing accuracy, quality and timely output of work
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs
- Perform testing such as Bioburden, Endotoxin, Total Organic Carbon, Concentration using UV-VIS, and Conductivity. (25%)
- Being honest and treating people with respect and courtesy
- Recording and reporting of test results with accurate data entry
- Conduct testing investigations, assist the area Team Leader in laboratory test scheduling, participate in assay transfers
- Follow experimental protocols and Standard Operating Procedures (SOPs)
present
Boston, MA
Quality Assurance Scientist
Boston, MA
Krajcik Inc
present
Boston, MA
Quality Assurance Scientist
present
- Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements
- Plans simple projects and may initiate and develop plans to ensure their timely completion
- Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility/laboratory
- Knowledge of Quality Risk Management
- Perform queries as necessary to respond to regulatory requests/inquiries
- Review of change management documentation
- Assess complaint information for determination of adverse event reporting and/or vigilance reporting
Education
Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Arizona State University
Bachelor’s Degree in Chemistry
Skills
Skills
- 3+ years of relevant, hands-on laboratory experience in an immunology or cellular biology setting
- Very experienced in IF, Flow Cytometry, and IHC
- Proficiency in aseptic technique and tissue culture
- Familiarity with basic lab equipment and knowledge of lab safety protocols
- Ability to effectively advance and work on testing and/or troubleshooting of multiple products simultaneously and to work in a dynamic and positive team environment
- Excellent communication and technical skills
- Ability to provide technical training to associates on flow cytometry, immunofluorescent microscopy, and IHC
- Ability to conduct troubleshooting and validation for process improvement. Be capable of writing SOPs or initiating any DCRs
- LI-TW
15 Quality Scientist resume templates
Read our complete resume writing guides
1
Quality Scientist Resume Examples & Samples
- Co-ordinate and conduct incoming materials and Finished product testing programme for the factory to meet Nestlé requirements
- Conduct and Support Packaging and Ingredient quality improvement activities
- Coordinate and deliver the Sensory Evaluation Training programme for York Factory
- Co-ordinate the surveillance and random testing programmes for the site to meet Nestlé requirements
- Carry out Hygiene / GMP Audits
- Support the Quality Assurance Specialist and Hygiene Manager
2
Water Quality EIT / Scientist Resume Examples & Samples
- B.E./B.S. in environmental engineering / science required; M.E./M.S. in applicable area a plus
- Would prefer previous environmental engineering experience, preferably in water quality, but will consider entry level candidate with solid educational background
- Excellent computer skills, including MS Excel and Word
- Programming and debugging skills (e.g., MATLAB, VB/VBA, FORTRAN)
- Self-motivated intellectual curiosity and the ability to learn through increasing
- Ability to work with self-direction in a project team environment
- GIS skills a plus
- Local candidates are preferred. Hiring preference will be given to Section 3 eligible residents
3
Quality Assurance Scientist Resume Examples & Samples
- 10+ years of experience with the principles and application of risk management
- 5+ years of experience of quality management in research and development
- 5+ years of audit experience
- Experience with fundamental statistical principles and practices
- Strong knowledge of regulatory requirements/guidance and development standards governing medical devices (e.g. US Medical Device Regulations, EU, Canadian, Japanese GMP, US and EU in vitro diagnostics (IVD) regulations, ISO 13485 and ISO 14971)
- Demonstrated oral, written, and interpersonal communication, and project management skills
4
Quality Control Scientist Resume Examples & Samples
- Perform environmental monitoring and collect utility samples in a cleanroom environment while following SOPs, sampling protocols, and associated documents. (50%)
- Perform testing such as Bioburden, Endotoxin, Total Organic Carbon, Concentration using UV-VIS, and Conductivity. (25%)
- Maintain and ensure sample chain of custody using a LIMS system and perform all aspects of sample management including aliquotting, storage, receipt, and shipping. (10%)
- Reconcile in-process testing samples at the end of the production run to ensure all samples were appropriately taken, processed, and were within required limits. (5%)
- Participate in lean lab operation, 5S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs. (5%)
- Perform Laboratory and Equipment maintenance. (5%)
- Ensure compliance with GMP policies and SOPs in a QC environment
- Weekend, holiday, and overtime work may be required as needed to meet production schedules
- Experience with cleanroom environmental monitoring and utility monitoring, microbiology, aseptic technique, Empower software, and working in a GMP biologics environment
- Bachelor's degree in life sciences, chemistry, microbiology, or other related degree concentration
- At least 1 year related laboratory experience (microbiology and environmental monitoring in a GMP biologics facility preferred)
5
Scientist Incoming Quality Resume Examples & Samples
- Incoming Quality (primary role)
- Experience with handling and receipt of raw materials
- Experience with measurement and inspection of raw materials
- Familiarity with labeling and packaging
- Previous quality experience (incoming quality preferred)
- Experience working in a GMP environment
- Prior laboratory experience and aseptic technique
- At least 6 months of experience
6
Quality Control Scientist Resume Examples & Samples
- Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to a contract-testing lab (Validation of methods will be phase appropriate)
- Establish specifications and testing process of raw materials
- Develop in-process and final specification system for drug substance and drug product of Kite cell therapy product
7
Quality Control Scientist Resume Examples & Samples
- Participate in the design and execution of analytical method development, and qualification and validation
- May manage analytical projects within the department
- Contribute to the understanding and interpretation of results and how they impact the design of subsequent experiments
- Contribute to development of project strategy in consultation with supervisor and/or colleagues
- May represent the organization in providing solutions to difficult technical issues associated with specific projects
- Being honest and treating people with respect and courtesy
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs
- Bachelor’s degree or equivalent and 10+ years of experience
- Master’s degree or equivalent and 5+ years of experience
- PhD or equivalent and 1+ years of experience
- Expert on one or more analytical platforms
- Experience in glycan analysis
- Knowledgeable in basic statistical applications
- Working understanding of relevant statistical methods
- Supervisory experience. #LI-GZ
8
Senior Quality Assurance Scientist Resume Examples & Samples
- Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices
- Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data
- Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers
- Contact customer with findings of CF/complaint investigation as needed, and document outcome of the customer call or write a customer letter
- Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans
- Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements
- Upon request, performs specific data queries, prepares complaint reports, and communicates the results
- Other duties and projects as may be assigned
- Ability to drive results, foster teamwork, handle pressure, and provide feedback
- Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations
- Hematology product knowledge
- Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations
- Able to apply extensive technical expertise and has full knowledge of other related disciplines
- Ability to perform detail-oriented work with a high degree of accuracy
- Proven ability to work cross-functionally in a team based environment
- Proficient in MS Office Suite of products
- Willingness to be flexible and adaptable to changing priorities
9
Quality Control Scientist Resume Examples & Samples
- A minimum of a Bachelor’s Degree (or equivalent degree) in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required
- A minimum of 2 years of GMP/GLP quality control lab experience in a pharmaceutical, OTC and/or highly regulated environment is required
- Experience with HPLC/UPLC testing methods is required
- Must be capable of performing routine laboratory activities
- Basic knowledge/exposure of a LIMS system is preferred
- Position will be located in Fort Washington, PA.Quality Control
10
Quality & Compliance Scientist Resume Examples & Samples
- Minimum 4 years of overall work experience in the functional area with at least 2 years experience in Peer review or Quality review
- Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports, preferred
- Required skills, abilities and competencies include
- Understanding of medical terminology preferred
- Ability to follow guidelines and procedural documents (experience of working with SOPs, etc. preferred)
- Oriented to quality, attention to detail necessary
- Ability to effectively delegate work responsibilities to others
- Ability to work both independently and in collaboration with others
- Proactive approach/uses own initiative appropriately
- Decision-making and problem solving skills
- Flexibility and adaptability
- Excellent computer skills (Word, email, PowerPoint) preferred, and especially in Excel (or Access)
- Familiarity with safety systems preferredRegulatory Compliance
11
Quality Control Scientist Resume Examples & Samples
- Responsible for scheduling of raw materials, intermediates, environmental monitoring samples, and finished goods submitted to the laboratory with minimal management oversight. Identify and implement initiatives for increasing lab efficiency
- Leads and executes laboratory, nonconformance, and CAPA investigations as assigned by management in compliance with procedures
- Ensures laboratory is functioning in compliance with SOPs, GLP, GMP, and HSE requirements. Perform safety and compliance audits of the laboratory and assist with or lead activities to address audit findings
- Performs GMP review of test data to ensure that test results meet all specifications. Trend data and analyze trends. Troubleshoot laboratory issues related to assays, methods, instruments, and equipment and recommend potential corrective and/or preventive actions and implements within the laboratory. May execute testing as assigned by management
- Leads and executes method transfers, method validations, and cross-functional projects with minimal supervision. Author technical documentation, assist in review of technical documents, and provide technical support. Recommend and implement revisions to standard operating procedures
- Utilize and troubleshoot LIMS; participate and/or led LIMS maintenance and validation activities
- Maintains personal training file. Responsible for training of other analysts as directed by management
- Perform any additional job related duties as requested
- B.S. with minimum of 6 years relevant experience preferred
- Advanced degree in relevant field can be substituted for experience
- In-depth technical and scientific knowledge with expert working knowledge of relevant laboratory techniques and quality principles
- Expert ability for use of software tools for data entry and analysis - In depth and practical understanding of GLP and GMP - Advanced technical writing skills
12
Quality Control Scientist Resume Examples & Samples
- Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations
- Review data for compliance to procedures and specifications
- Calculate and evaluate results
- Assist in the design and execute analytical method development, and qualification and validation
- Assist in the development, revision and authoring of complex, explicit documentation, i.e. new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics
- Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process; solve assay/analytically-related process problems
- May participate in coordination of completion of specific project tasks with other departments
- May contribute to development of project strategy in consultation with supervisor and/or colleagues
- Work under limited supervision and direction
- May participate in determining objectives of assignment
- Represent the organization in providing solutions to basic technical issues associated with specific projects
- May manage analysts
- May interact with other Genzyme functional areas or teams
- Bachelor’s degree or equivalent and 8+ years of laboratory experience
- Master’s degree or equivalent and 5+ years of laboratory experience
- PhD degree or equivalent and 0-2 years of laboratory experience
- Expert in one or more analytical platforms
13
Scientist, Reagent Quality Control Resume Examples & Samples
- Performs analytical and functional QC testing utilizing work instructions and batch records for release of materials to production inventory
- Completes analysis and documentation of test results. Review data to verify conformity to specifications and report abnormalities
- Operate laboratory and review data from a wide range of equipment such as spectrophotometers, fluorimeters, HPLCs, thermal cyclers, bioanalyzers, pH meters, sequencing equipment and other equipment
- May have additional roles to validate equipment, perform assay validation, or complete stability studies (as needed)
- The ideal candidate must have a Bachelors and/or Masters in biological or other
- Candidate must be a team player who is self-driven, motivated, organized, analytical, detailed, and flexible in a fast-paced environment
- He/she should have a broad based technical knowledge of laboratory practices and of analytical equipment (i.e. HPLCs, spectrophotometers, etc.)
- Commercial manufacturing/QC experience in an ISO 13485 regulated company is preferred
- Proficiency in molecular biology DNA sample preparation and DNA sequencing a plus
14
Quality Control Scientist Resume Examples & Samples
- Perform routine analysis on complex laboratory equipment including HPLC and GC systems
- Qualify and implement new equipment and technology to the QC laboratory
- Develop and author complex and explicit documentation for new and current procedures and technical reports
- Practice safe work habits and adhere to Genzyme's safety procedures and guidelines
- Provide technical leadership and guidance for the successful completion of major laboratory projects
- Implement new quality control procedures
- Bachelor’s degree in Life Sciences discipline and 8 years of experience in CGMP lab environment, or Master’s degree in Life Sciences discipline and 6 years’ experience in CGMP lab Environment
- Experience with ELISA test procedures
- Project Management experience to manage projects throughout the lifecycle including identifying and meeting key milestones
15
Quality Control Scientist, Stability Resume Examples & Samples
- Responsible for stability studies across all compounds in a compliance with ICH, WHO, company quality guidelines and SOPs in support of the company’s timelines and goals
- Perform stability sample inventory and pulling of stability samples per approved protocols
- Perform routine stability testing in support of cGMP stability studies
- Perform non-routine testing as part of the method qualification and optimization activities
- Trend routine stability data to support product shelf-life and retest extension activities
- Participate in investigations as part of an OOS and/or troubleshooting of methods and test equipment
- Support the QC team with routine tests for in-process control and lot release and assist with data review
- Participate in review and creation of new and existing SOPs
- Have responsibilities in activities related to preventive maintenance, qualification and calibration of stability chambers
- Share responsibilities with the team to support sample and equipment management
- Assist in maintaining the QC lab and its systems in a cGMP compliant state
- Contribute to team building, training and problem-solving initiatives
- Communicate effectively verbally and in writing
- Ability to work independently with little or no direct supervision
- Establish and maintain work schedule goals
- Good knowledge of statistical interpretation, trending of stability results and cGMP practices
- Ability to multi-task, effectively manage timelines, great attention to detail and team-oriented personality are a must
16
Quality Assurance Scientist Resume Examples & Samples
- 3rd level qualification in Science, Engineering or Quality Assurance
- Minimum of 2 years experience in a highly regulated (FDA desirable) healthcare or related environment
- Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management
- Excellent interpersonal / communication skills
- Strong team member with the ability to identify and drive quality improvements
- Excellent Planning and organisational skills
17
Quality Scientist Resume Examples & Samples
- Testing of samples from manufacturing to ensure Quality and compliance according to all applicable assays utilizing good aseptic practices
- Understand the performance of the assays responsible and support all critical reagents with guidance
- Maintain testing schedules with minimal direction and guidance
- Execute and report validation studies
- Write and revise Standard Operating Procedures and Standard Methods
- Support Investigations when necessary utilizing Method 1 and the DMAIC process
- Clean and maintain lab equipment, instrumentation and facilities
- Properly navigate the QC software packages used during routine work
- Preparation of media and reagents
- Participate in Media Fill inspections
- Responsible for monitoring of lab equipment
- Responsible for completing Gram Stain work
- Follow all saftey practices
- Solid understanding of several of the basic technologies for their specificed workgroup and be able to work independently
- Understand the basic functions of other parts of the organization
- The colleague may participate on simple projects or participate as part of a team on larger projects
- Maintain appropriate departmental cGMP documentation
- Execute all written procedures
- Effectively work in a team environment and communicate with multiple departments
- General knowledge of the following software programs: Word, Excel, and Powerpoint
- Strong attention to detail, ability to work well independently and as a part of a team, and to work effectively with people at all levels within the organization
- Gain Profiency in 70% of the testing in a specified area
- Able to follow detailed instrcutions with minimal coaching
- Knowledge of Basic GLP requirements
- Strong Problem solving skills and should demonstrate troubleshooting abiltity
- Project work that may have unit impact
18
Quality Scientist Resume Examples & Samples
- Maintain testing schedules and reagent supply
- Provide basic input for laboratory investigations (LIR)
- Provide basic project support
- Complete pippette work and understand the proper use of pippettes
- Complete pH and Appearance testing
- Complete proper Egg Drilling
- Basic problem solving skills and demonstrate trouble shooting ability
- Gain Profiency in 50% of the testing in a specified area
- Able to follow detailed instrcutions with coaching
- Basic Problem solving skills and should demonstrate basic troubleshooting abiltity
19
Quality Control Scientist Resume Examples & Samples
- Perform flow cytometry, IHC, and IF testing of a variety of products such as protein and chemical reagents, buffers and especially antibodies, and antibody kits and cocktails through surface, intracellular, and multicolor staining
- Data acquisition and analysis on a variety of flow cytometers and analysis software systems
- Use, maintain, and update internal databases such as FileMaker and others in a timely manner
- Work with mouse and human tissues/samples
- Perform cell culture and set up of cell stimulations
- Monitor progress and conclude product testing in a timely manner
- Generate data summaries and provide ETAs for product testing and outcome
- Follow experimental protocols and Standard Operating Procedures (SOPs)
- Maintain facilities and lab equipment and monitor the status of pipettes and supplies as needed
- Perform other laboratory duties as assigned
- Bachelor's or graduate level degree in a field of Life Sciences (immunology or cellular biology preferred)
- 3+ years of relevant, hands-on laboratory experience in an immunology or cellular biology setting
- Very experienced in IF, Flow Cytometry, and IHC
- Proficiency in aseptic technique and tissue culture
- Familiarity with basic lab equipment and knowledge of lab safety protocols
- Ability to effectively advance and work on testing and/or troubleshooting of multiple products simultaneously and to work in a dynamic and positive team environment
- Excellent communication and technical skills
- Ability to provide technical training to associates on flow cytometry, immunofluorescent microscopy, and IHC
- Ability to conduct troubleshooting and validation for process improvement. Be capable of writing SOPs or initiating any DCRs
20
Quality Control Scientist Resume Examples & Samples
- Assist in troubleshooting and validation for process improvement
- Assist in writing SOPs and initiate DCRs
- Serve as point person between QC and PD groups to assist QC Manager with smooth transfer or products
- Assist QC Manager with data review
21
Quality Assurance Scientist Resume Examples & Samples
- Analyzes clinical data, performs testing on filed complaints that may include customer returns
- Contacts customers as needed
- Generates and prepares quality data reports
- Ensures potential reportable events are submitted to site regulatory agency reporting
- Performs assignable cause investigations to identify potential failure modes and failure mechanisms
- Investigates and follows up on analysis of complaint trend reports
- Knowledge of Immunoassay product lines. Excellent systems knowledge (instrument hardware as well as reagents) is highly desired
- Excellent writing and organizational skills
- Good computer skills to include Microsoft applications such as Word, Outlook and Excel
- Work may be independent/flexible, so an ability to manage time and productivity to meet department metrics and a high level of personal integrity is required
- Bachelor´s degree in Science field with 3 years of relevant experience required
- Medical Technology/clinical laboratory background preferred
- Experience in Complaint Investigation or Post Market Surveillance/QA preferred
- Basic knowledge of statistics/quality control desired
22
Quality Scientist Resume Examples & Samples
- Testing in process samples, (including but not limited to Environmental Monitoring (EM), Water Samples, Seeds, Antigen), blended vaccines and final containers for all applicable assays utilizing good aseptic practices with minimal supervision. Chemistry and/or microbiology disciplines involved with testing
- Understand the performance and trending of the assays responsible for and maintaining all critical reagents with minimal guidance
- Maintain daily testing schedules
- Execute and report laboratory investigational protocols
- Write investigations when necessary utilizing Method 1 and the DMAIC process of their own work and assist in the investigations of work done by others
- Assist with outline of production reviews as required
- Properly navigate the QC software packages used during routine work. Assume an administrative role as required
- Trending analysis and write quarterly reports as required by ZQS
- Assist with peer data reviews
- Participate in the Select Agents program training and/or testing as needed in QC lab 9343, as applicable to workgroup
- Work independently and exercise good time management for assigned workload (High level of productivity)
- Complete verification of peer’s work
23
Research Scientist, Quality Resume Examples & Samples
- Coordinate and conduct independent investigational testing/analysis, including data collection and
- Analysis under supervision
- May write and execute protocols
- May acquire images by using the Digital Microscope System if needed
- Participate in special projects related to evaluation of existing and developmental
- Products and processes
- Prepare and document laboratory data in accordance with FDA, ISO (Internal
- Standards Organization), and in-house guidelines
- Prepare technical findings reports, summaries, protocols, and quantitative
- Analysis. Observe and draw conclusions regarding testing performed. Maintain
- Accurate and complete records, methods, measurement and observations related
- To assigned projects/evaluations
- Good computer skills in usage of MS Office Suite
- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills
- Good understanding and knowledge of principles, theories, and concepts relevant to a laboratory environment
- Good problem-solving, organizational, analytical and critical thinking skills
- Good understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate
- To medical device manufacturing
- Strict attention to detail
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors
- A bachelor’s degree in Engineering or other scientific field is required
- Experience working in a medical device, pharmaceutical industry and/or lab environment is preferred
24
Product Quality Senior Scientist Resume Examples & Samples
- Product Quality and Compliance for Cell and Gene Therapy products under development and in commercial supply within GSK or at third parties
- Ensuring local compliance with QMS, Pharmacopoeia and Regulatory Guidance
- Authoring and managing local SOPs and quality systems
- Continuous Quality Improvement
- Participate in internal and external audits
- Co-ordinating, Authoring and implementing local quality systems and SOPs
- Track compliance of GMP Operations local standard operating procedures with Quality Management System, Pharmacopoeia, Regulatory Guidance and best practice. Track and close out actions to fill any gaps
- Maintenance of Training Curricula
- Schedule local quality and safety inspections and track completion of actions
- Work with representatives of the wider Cell and Gene Therapy department to ensure integration with department wide systems
- Local business administrator for electronic systems
- Own QC Documentation system
25
Senior Water Quality Scientist Resume Examples & Samples
- California Professional Engineer (PE) registration in Civil Engineering, with demonstrated experience in designing and constructing drainage facilities with emphasis on green infrastructure
- Demonstrated experience with hydrology and hydraulics (H&H), San Diego County Hydrology Manual, County Hydraulics Design Manual, and City of San Diego municipal storm water standards, including municipal Standard Urban Stormwater Mitigation Plans (SUSMPs), and Hydromodification Management Plan (HMP) engineering and analyses
- Experience preparing Hydromodification Management Plans, and Drainage Reports, including supporting AutoCAD/GIS analyses
- Experience with floodplain determinations and delineations, flood control analyses, and risk assessment and management
- Experince leading preparation of construction plans, specifications, cost estimates, and planning/engineering reports. Prepare conceptual designs and construction plans using GIS, AutoCAD and/or Microstation software
- Experience with stormwater conveyance capacity analyses and hydrologic/hydraulic modeling knowledge, particularly with StormCAD, MIKE suite of software, EPA SWMM, and HEC-HMS/HEC-RAS
26
Quality Control Scientist Resume Examples & Samples
- Plan and execute Quality Control testing of intermediate/finish products
- Ensuring testing is performed in accordance with standard operating procedures, guaranteeing accuracy, quality and timely output of work
- Recording and reporting of test results with accurate data entry
- Raise and execute investigations out of specification or out of trend results, including design and execution of Corrective and Preventative Actions
- Develop and maintain documentation and records in accordance with GMP and company requirements
- Participating in continual improvement activities and new product introductions within the laboratory
- A tertiary or equivalent qualification in a science discipline (microbiology and/or immunology preferred)
- Experience working with aseptic techniques in a GMP laboratory environment (desirable)
- Knowledge of APVMA and other regulatory bodies’ requirements is advantageous
- Sound project management skills with ability to initiate and complete project outcomes within given timeframes
27
Water Quality EIT / Scientist Resume Examples & Samples
- Acquire, organize and analyze environmental data from a variety of sources
- Set up and execute mathematical models
- Perform quality-control checks on model input and results
- Develop statistical and graphical (static and animations) comparisons of model results and data
- Participate in project meetings, proposal preparation, report writing and presentations
28
Quality Assurance Scientist Resume Examples & Samples
- Assess complaint information for determination of adverse event reporting and/or vigilance reporting
- Verify accuracy and completeness of pertinent records and documentation
- Possess understanding of risk management concepts and is capable of assessing product risks across unit of work
- Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities
- Provide input to project teams on project specific processes and deliverables. Ensure completion of key deliverables
- Perform queries as necessary to respond to regulatory requests/inquiries
- Other duties and projects as assigned
- Experience participating on cross functional teams
- Diagnostics product knowledge is a plus
- Position may be upgraded based on relevant experience
- Able to make judgment calls and solve problems using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations
- Excellent English oral and written communication skills
- Effective analytical and problem solving skills
29
Senior Quality Assurance Scientist Resume Examples & Samples
- 8+ years in industrial experience in quality organizations, in either operations or assurance functions
- B.S or B.A in a relevant scientific, quality system or technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience
- Master’s degree in science, regulatory or business discipline
- Certification such as ASQ Certified Quality Auditor preferred
- Capable of doing presentations
- MS Excel and Word advanced skills
30
Quality Control Systems Scientist Resume Examples & Samples
- Initiate/create, route, revise, and/or review 10 documents/GMP records a day on or as required average
- General support activities for Quality Control laboratories and Quality Operations department
- Documentation creation, revision, and processing; technical writing
- Stability activities (e.g. Stability documentation creation, revision, and processing; sample time point pulls; organization; LIMS study creation, trending)
- Training support
- Equipment/instrument activities associated with implementation, calibration and maintenance
- Data Integrity Remediation activities
- Basic LIMS tasks (etc. minor builds)
- Investigation and change control support
- Assist with continuous improvement efforts
- Support training of new staff within immediate team; mentoring and coaching junior colleagues
- Create, review, and approve test method and/or equipment validation records with limited guidance/coaching
- Experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances
- Method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues)
- Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples
- Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance
- Responsible for appropriate creation, review and approval of GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values
- Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
- Assessing existing situations and suggesting improvements to increase compliance and innovation
- Knowledge cGMP
- Experience with Microsoft Office specifically Excel and Word
- Knowledge of analytical chemistry and/or Microbiology techniques and instrumentation
- Knowledge of Lean Labs
- Manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
- Minimum of 6 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
31
Quality Assurance Scientist Resume Examples & Samples
- Attend 1 to 2 Scope Prioritization meetings daily or as required
- Review of site documentation (i.e. Batch Records, SOPs, technical reports, protocols, etc.)
- Review of change management documentation
- Review/Approval of site investigations
- Raw Material enrolment activities
- Document Revisions (i.e. SOPs, Quality Agreements, Supplier Change Notifications)
- Support activities for Batch Issuance and Document Control/Retention
- Support activities for Training Compliance
- Support of QA Shop Floor record review
- Responsible for knowing, understanding and acting in accordance with cGXP Pfizer’s values and our OWNIT culture
- Providing Quality Review/Oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards
- Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility/laboratory
- Plans simple projects and may initiate and develop plans to ensure their timely completion
- Able to competently review/disposition batch record with increased complexity and associated simple deviations
- Able to resolve issues and independently make simple batch disposition decisions on incoming components/raw materials under limited guidance/coaching
- Able to review and approve executed validation records and deviations under limited guidance/coaching. Set acceptance criteria for validation under limited guidance/coaching
- Support training of new staff within immediate team
- Able to execute and approve supplier reassessments and build supply channels
- Utilize method 1, yellow belt tools to address simple problems and continuous improvement ideas under limited guidance/coaching. Knowledge of basic QRM principles. Completes basic tasks with minimal oversight
- Knowledge of current US, EU, and ROW cGXP
- Knowledge of Quality systems
- Knowledge of LIMS
- Experience with Microsoft Office specifically Word and PowerPoint
- Knowledge of Lean Six Sigma concepts
- Knowledge of Quality Risk Management
- Experience with Global Quality Tracking System (TrackWiseTM application)
- Minimum of 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
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Quality Control Scientist Resume Examples & Samples
- Potency test raw materials, experimental samples, in-process lot material and final product animal vaccines by Enzyme-Linked Immunosorbent Assay (ELISA) for USDA release and subsequent sale in accordance with regulatory and internal requirements
- Conduct testing investigations, assist the area Team Leader in laboratory test scheduling, participate in assay transfers
- Prepare and participate in Internal, Corporate, USDA and Environmental Health and Safety (EHS) audits
- Review internal documents against regulatory requirements for accuracy and compliance
- Work on special projects and stretch assignments as assigned
- Ability to work successfully in a team-oriented environment and coordinate multiple projects
- Ability to effectively follow procedural guidelines
- Strong computer skills with excellent communication and writing skills
33
Quality Assurance Scientist Resume Examples & Samples
- Investigate incidents related to discovery of non-conforming product within the facility and provide direction to production supervision and Facility/QA Management to assure proper containment and recovery of operations. Coordinate the response to incidents involving multidepartment and multi-facility impact to assure containment and guide business decisions to reduce potential customer complaints. Coordinate the activities/tasks with technicians, business unit leaders, and less experienced professionals as required
- Conduct detailed investigation of each NCP incident to establish root cause identification
- Communicate Category 1 NCP information and complimentary information as needed to ALCS Analytical Technical Services, ALCS Product Integrity, and ALCS Quality Control. Provide disposition recommendations on Category 1 NCP incidents based on root cause analysis, analytical results, the scope of the NCP, and market requirements
- Provide disposition decisions on Category 2 NCP incidents based on root cause analysis, analytical results, the scope of the NCP, and market requirements
- Provide inventory reconciliation of NCP hold work within the manufacturing facility and/or customer facilities
- Recognizing process & lab discrepancies/trends and taking the appropriate actions
- Preparing memos, reports and making informal presentations as requested
- Support the maintenance of laboratory test methods and validation plans
- Supporting lab/process improvements which include some interpretation and generation of data analysis, as well as troubleshooting basic lab instrumentation and process activities. This position serves as the site laboratory calibration coordinator
- Working knowledge of the following equipment
- Bachelor’s degree in Chemistry, Biology, related physical Sciences or equivalent combination of education and experience
- Technical knowledge and skills to include, but not limited to Gas Chromatography, HPLC, Densitometer, Auto-refractometers, LCMS, GCMS and other standard analytical instrumentation
- Excellent communication skills both oral and written are required
- A working knowledge of statistical concepts (i.e., control chart theory/application, performance, trend analysis, cause and effect relationship, trend analysis, etc) and proficient computer skills and software application knowledge
- Demonstrated leadership skills, analytical testing/methodology and coordinate activities/tasks of technicians and contractors
- Proficient with MS Office (Word, Excel, PowerPoint, Outlook), Laboratory Information Management System (LIMS), and SAP
34
Quality Assurance Scientist Resume Examples & Samples
- Bachelor’s degree in Chemistry, Biology, or similar scientific field with 2+ years exp. OR
- Master’s degree in Chemistry, Biology, or similar scientific field with 0-2+ years exp
- Experience in quality assurance preferred
- Experience with collaborative cross-functional teams desirable
- Strong understanding of ISO 13485 and FDA GMP regulations for Medical Diagnostics industry
- Good understanding of risk management, FMEA, validation, and design controls
- Good understanding of manufacturing product quality assurance. CQE strongly preferred
- Experience with diagnostic reagents for general chemistry and immunochemistry preferred
- Good understanding of basic laboratory techniques
- Strong problem solving and conflict resolution skills
35
Device Quality Assurance Scientist Resume Examples & Samples
- Bachelor's Degree in engineering or life science preferred
- 7 + years of experience in a quality management role in medical device industry
- 3+ years of design control experience of diagnostics product
- Demonstrated leadership/influencing skill in highly matrix organization
- Knowledge of Molecular and Immunohistochemistry Pathology
- Knowledge of clinical laboratory accreditation requirements, e.g., CLIA, ISO 15189
- Regulatory submission experience
- Third Party/Alliance Quality Management
36
Scientist, Quality Laboratory Resume Examples & Samples
- Performing with competence, upon training, routine testing following laboratory test methods and procedures
- Developing a competence, upon training, in the use of laboratory instruments and equipment
- Performing daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment per current SOPs
- Working in compliance with current GMPs regarding documenting, testing and maintaining accurate laboratory notebooks and data sheets
- Initiation and participation in laboratory investigations of non-conforming laboratory test results
- Collecting and preparing laboratory records for evaluation following good documentation practices
- Ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
- A Bachelor of Science Degree is required
- 0 to 2 years’ experience is required
- A minimum of 2 relevant internships are strongly preferred
- Good interpersonal, organizational and communication skills
37
Quality Control Scientist Resume Examples & Samples
- Track and test products according to stability protocols
- Monitor and trend data; complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
- Generation of CoAs for product release
- Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies
- Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections
- Conduct investigations regarding out of specifications (OOS) results
- Address and manage deviations related to analytical procedures
- Provide updates to the Associate Director of Quality Control as needed
- Gather metric information for use in continuous improvement of areas of responsibility
- Interacts with all levels of management
- Contribute to the development of QC Departmental Strategies
- Actions may have implications on operations and budget
- Bachelor or Master's degree in biotechnology or related field with 4 -- 5 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 1-2 years of Quality Control experience
- Strong knowledge of GMP, SOP's and quality control process
- Identifying, writing, evaluating and closing laboratory (OOS) investigations
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Experience in the biotech and/or pharmaceutical industry
- While most of the schedule will be during a standard work-week, there will be occasional weekend work required
38
Quality Assurance Scientist Resume Examples & Samples
- Excellent writing and organizational skills. Good computer skills to include Outlook email and other Microsoft applications such as Word, Excel and Power Point
- Knowledge of Oracle database application desired
- Heavy multi-tasking and organizational skills required
- Bachelor´s degree with 0-2 years’ experience in Technical Field (Science or Engineering) and/or Compliance (Complaints, Quality or Regulatory)
39
Data Scientist, Quality Outcomes Resume Examples & Samples
- Master’s degree in Statistics, Mathematics, Computer Science, Informatics, Econometrics, Engineering, Experimental Science with 5+ years of experience OR
- Bachelor’s degree and 7+ years of quantitative analysis experience in data science capabilities including data mining, predictive modeling, machine learning, statistical modeling, large scale data acquisition, transformation, and structured and unstructured data analysis
- SQL Server/Teradata; proficiency in one or more statistical analysis programs including SAS, SPSS, Excel, R; experience with data visualization and reporting software including Tableau, Excel, PowerBI, R
- Healthcare experience preferred. Experience managing projects or heavy involvement in project implementation
40
Assistant Quality Control Scientist Resume Examples & Samples
- Do you have a minimum of a BS degree in scientific area with at least 1 year experience with experience with ELISA, qPCR, SDS-PAGE, IEF and/or cell culture testing?
- Do you have solid pipetting and micro pipetting skills?
- You will be asked to perform Quality Control testing for in-process, release, and stability in a cGMP environment
- You also will be performing data review, ensuring the laboratory cGMP compliance is maintained, executing technical transfer and co-validationing activities
- Perform instrumentation verification/preventative maintenance, assist with laboratory investigations
41
Quality Assurance Scientist Resume Examples & Samples
- Degree level in a Science or Engineering related discipline
- 2 years’ experience in a laboratory environment or Quality role
- Good knowledge of FDA QSR and ISO13485 requirements
- Good Troubleshooting skills
42
Scientist, Quality Resume Examples & Samples
- Execute and provide on-time completion of Quality engineering deliverables
- Work without appreciable direction, identifies, plans, recommends, and carries out technical projects and investigations generally related to medical device combination products
- Interpret data and adhere to strict guidelines on documentation when recording data
- Has the ability to report scientific data and disseminate findings and product implications to management, engineers and other internal customers
- Has the capability to use a range of analytical techniques, instrumentation and software (such as gas chromatography and high performance liquid chromatography (HPLC))
- Has the ability to review analytical methods, including API, raw materials, in-process and finished drug product
- Anticipate, recognize and resolve technical issues through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation
- Perform technical and quality risk assessments and direct activities of other scientists as well as provide training and development for others
- Appropriately document experiment plans and results, including protocol writing and reports
- Support the investigation, resolution and prevention of product and process nonconformances and out of specifications
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Performs other related duties and responsibilities, on occasion, as assigned
- Bachelor’s degree in relevant engineering (chemical) or scientific discipline and a minimum of 2 years of related experience
- Strong technical leadership skills including the ability to coach and mentor less experienced employees
- Experience working Experience working in a broader enterprise/cross-division business unit model preferred
- Ability to leverage and/or engage others to accomplish projects
- Ability to travel approximately 10%, including internationally
- Master’s degree or PhD in relevant engineering or scientific discipline preferred
- ASQ CQE preferred
- Prior medical device, pharmaceutical or drug/device combination product experience preferred
- Root cause analysis/problem solving training and experience preferred
43
Senior Scientist, Reagent Quality Control Resume Examples & Samples
- Lead or participate in cross-functional team efforts to develop, validate, and implement quality control test methods for new reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies
- Partner with Genomic Sciences, Biostatistics, and other functions in the development and use of appropriate test methods for characterizing the composition, functional performance, and stability of reagents and consumables required for the development and launch of new products
- Draft and implement new procedures, documents, and forms associated with reagent quality testing
- Collaborate closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to address and prevent supplier quality issues
- Ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities
- Additional responsibilities as assigned
- Bachelor’s degree in a molecular biology, biochemistry, chemistry, or an associated relevant field with 10+ years relevant industrial experience. Advanced degree preferred
- Strong background in biochemistry and molecular biology methods with experience in reagent development, manufacturing, and QC for nucleic acid isolation, purification and quantitation, qPCR, and next generation sequencing assays
- Experience with transfer and scale up of new products and processes to manufacturing and/or QC
- Highly motivated, detail oriented individual with consistent record in solving technical problems effectively and efficiently
- Strong communicator with ability to maintain open communication and collaboration with colleagues, management, and suppliers as needed
- Ability to prioritize and adapt to changing priorities while maintaining a high standard on quality
- Ability to work in a fast paced, multidisciplinary and dynamic environment and capable of handling multiple activities simultaneously
- Previous experience in working under ISO13485 quality system and design control practices is highly desirable
44
Quality & Food Safety Senior Scientist Resume Examples & Samples
- Create an aligned/ harmonized QMS process with the Central European team
- Define the road map that will lead to full compliance to our global and regional standards
- Create and implement an internal auditing schedule which will both identify gaps in our compliance and align on a gap closure plan
- Define and drive the delivery of the HUB Pre-requisite Program (PRP) that underpins the HACCP requirements, and relationship to Mars Global Standards for Quality & Food Safety
- Ensure that there is a road map for systems development and implementation eg Nexus, Veritas
- Design & deliver the appropriate training & awareness to Hub associates for the standard and systems that are in place today or being develop in the future
- Executing HUB based projects or sub-projects within this role which has multiple dimensions- medium scope and complexity across functional / technical, people and organisation
- University degree in science or similar technical field (Mandatory)
- On the job experience in a technical field within an FMCG environment or similar business (Mandatory)
- Professional knowledge ISO 9001, ISO 22 000 & HACCP (Desirable)
- Auditor trained (Desirable)
- Computer proficiency in MS Office applications (Desirable)
45
Quality Control Bioassay Scientist Resume Examples & Samples
- Perform testing and data review for bioassay methods, cell culture, and routine laboratory procedures
- Strive to achieve excellent client service
- Technical expertise for executing methods in one or more of the following areas: bioassay testing, cell-based assays, cell culture, strong pipetting skills, and aseptic technique
- B.S., or MS degree in Cell Biology, Molecular Biology, Immunology, or related technical discipline
46
Water Quality Scientist Resume Examples & Samples
- Five (5) years experience in a field related to water and/or sludge/soil quality testing with a concentration in wet chemistry
- Experience in a TNI accredited laboratory
- Experience analyzing municipal drinking water, wastewater, and/or sludge/soil samples
- Experience troubleshooting laboratory equipment
- Drive to various sites throughout the city including schools, wastewater plants and area water ways to collect samples
- Prepare and analyze water, wastewater or environmental samples
- Perform appropriate analysis per established protocols
- Follow strict analytical and documentation protocols
- Maintain Chain of Custody process
- Evaluate, verify data
- Notify appropriate staff of non-compliant or out of spec results
- Adhere to QA/QC and standard operating procedures
- Operate, maintain, and calibrate, analytical/miscellaneous instrumentation
- Perform proficiency tests and other quality assurance procedures
- Prepare reagents and/or media
- Assist with administrative duties as required
- May be required to testify regarding analyses performed
