Scientist, Quality Control Job Description
Scientist, quality control
provides technical and compliance guidance to the QC laboratory with strong analytical techniques and troubleshooting skills in HPLC/GC/UV/IR/Dissolution etc.
Scientist, Quality Control Duties & Responsibilities
To write an effective scientist, quality control job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, quality control job description templates that you can modify and use.
Sample responsibilities for this position include:
Responsible for appropriate creation, review and approval of GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, ) and ensuring adherence to Pfizer standards, guidelines and values
Generate design of experiments, qualify and validate analytical test methods, including supporting documentation, protocols, reports
Perform regular lab walk-throughs for quality, compliance, and safety
Ensure departmental SOPs are within biennial review date
Maintain training curricula for employees
Track and maintain metrics for laboratory testing and investigations (DVs, LIs, events, change control, CAPA) on a regular basis
Ensure daily QC laboratory real-time data review and audit and provide appropriate hands on training as required
Serve as department point person for laboratory audits, including follow up and reports
Approve COAs for release (focus on accuracy of reporting, mass balance, batch quality)
Responsible for QC approval of SOPs, STMs, study reports, validation protocols, specifications and deviations
Scientist, Quality Control Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Scientist, Quality Control
List any licenses or certifications required by the position: ASCP, HT, FSSC, 9001, ISO
Education for Scientist, Quality Control
Typically a job would require a certain level of education.
Employers hiring for the scientist, quality control job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Science, Biology, MBA, Life Sciences, Biochemistry, Engineering, Biotechnology, Microbiology, Manufacturing
Skills for Scientist, Quality Control
Desired skills for scientist, quality control include:
GC
Microsoft Word and Excel
Dissolution Testing
FT-IR
Karl Fischer
MS
UV-Vis
Empower Software and Statistical software
Characterization and transfer of pharmaceutical products
GMP
Desired experience for scientist, quality control includes:
Review and approve analytical method validation/transfer protocols and reports with a focus on compliance aspects/deviations
Manage the transfer and validation of analytical methods from Analytical Development to QC the transfer and validation of methods to a contract-testing lab (Validation of methods will be phase appropriate)
Experience in the biotech and/or pharmaceutical industry is preferred
The ideal candidate is well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals
Quality Control, GMPs, bioanalytical method development and validation
Identifying, writing evaluating and closing OOS’s and investigations
Scientist, Quality Control Examples
1
Scientist, Quality Control Job Description
Job Description Example
Our company is looking to fill the role of scientist, quality control. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, quality control
- Assist in the development, revision and authoring of complex, explicit documentation, new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics
- Completes analysis and documentation of test results
- Work with Protein Production and Chemistry Groups to perform analytical methods development and validation
- Evaluate and possibly implement new techniques and technologies
- Work on individual projects independently with no supervision
- Perform under cGMP practices
- Collaborate with scientists both external and internal (Clinical Science and Technology, Process Biochemistry, Analytical Development, Research)
- Manage validation projects
- Perform testing of incoming raw materials by sampling materials, confirming specifications
- Performs Microbiological test methods as written to support product/material release
Qualifications for scientist, quality control
- Knowledge of analytical methods for enzyme activity assays, oligonucleotide purity and composition using HPLC and spectroscopic techniques, and qPCR-based functional testing
- Equipment and utility URS/FRS/IQ/OQ/PQ/PV
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, our own Company policies and procedures
- Expert on analytical platforms
- A Bachelor of Science in chemistry, pharmaceutical science or closely related field, and a minimum of 12 years of related experience in the pharmaceutical/biopharmaceutical industry or quality control environment
- May require 10 – 15 % travel for meetings, to collaborator sites, or to contract organizations including serving as a technical SME during quality audits
2
Scientist, Quality Control Job Description
Job Description Example
Our innovative and growing company is looking for a scientist, quality control. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, quality control
- 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)
- Conduct microbiological and analytical analyses following standard operating procedures (SOPs)
- Compile data and records results
- Review results for compliance to specifications and reports deviations
- Analyze data and prepares reports, upon request
- Prepare and revises SOPs and test methods, as required
- Conduct necessary maintenance and calibration of lab equipment
- Conduct problem solving on analytical and instrument issues, as required
- Apply knowledge of good laboratory practices daily
- Performs method transfer to and training of toll manufacturing personnel
Qualifications for scientist, quality control
- He/she should have a broad based technical knowledge of laboratory practices and of analytical equipment
- Product testing and data analysis for product release (involves calculations, measurements, immunological techniques)
- Independently solve complex problems and deal with a variety of variables in situations where only limited information is available
- New Product Introduction-run assays, data review, cross functional communication, Biological Sample tracking and establishing reference samples for product testing
- Identify and troubleshoot potential problems and proactively suggest technical solutions based on analytical expertise, knowledge of the product and knowledge of the customer
- Out of Specification and/or CAPA Investigation and Root cause analysis- Design experiments to perform in - depth investigation if product failure is suspected
3
Scientist, Quality Control Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of scientist, quality control. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, quality control
- QPCR gene expression
- Write reports as needed and enter data in software programs
- Participate in the transfer and qualification/validation of analytical methods from Analytical Development to QC the transfer and validation of methods to QC Commercial and to contract-testing lab
- Troubleshoot assay and instrumentation issues
- Manage activities at contract laboratories, including analytical method validation/qualification, ID testing, release testing, stability testing, investigational testing
- Develop, manage and monitor stability programs for commercial products, clinical trial materials, and developmental projects
- Review test results/raw data to ensure that results meet specifications, test procedures were followed, and laboratory work is documented appropriately
- Provides analytical support to Tech Ops functional groups
- Possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence
- Perform testing and data review for compendial, non-compendial methods, and routine laboratory procedures (experience with USP/EP is preferred)
Qualifications for scientist, quality control
- Knowledge of cGMP regulations
- Annual Product Review and evaluation- aid in yearly technical review of products, evaluation of baseline data and correlations between trend analysis and customer feedback
- Represent Quality in cross-functional applications
- Independently analyze, summarize and interpret data in order to present and make decisions
- Chemical Safety Training Program
- Bloodborne Pathogen Training Program
4
Scientist, Quality Control Job Description
Job Description Example
Our growing company is looking for a scientist, quality control. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for scientist, quality control
- Possess thorough knowledge of methods for data trend analysis and stability data behavior
- Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the Global Stability organization
- Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional)
- Participate on Asset sub-teams and maintain thorough knowledge of CMC program for assigned products
- Perform release and stability bioassay testing
- Perform ELISA testing, basic protein characterization and troubleshooting
- Address technical reagent and ELISA kit issues
- Write documents including SOP and SDS forms and review Document Change Requests
- Review completed data reports
- Perform routine preventative maintenance on laboratory equipment such as plate washer, microplate coating machine, and pH meter
Qualifications for scientist, quality control
- Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience working in a cGMP compliant environment
- In-depth understanding of individual area of work and related disciplines
- Perform sample submission to QC lab and contract laboratories
- Preparation of buffers/reagents
- The ideal candidate is well versed in various analytical techniques such as FTIR, Osmolality, pH, Density and other applicable methods to the testing of raw materials
- While most of the schedule will be during a standard work-week, there may be occasional weekend work required
5
Scientist, Quality Control Job Description
Job Description Example
Our company is looking to fill the role of scientist, quality control. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, quality control
- Lead and participate in efforts to support the development of IVD products under design control in conformance with ISO 13485(2016)
- Collaborate closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to facilitate effective, efficient process transfer and ensure supplier and OEM vendor quality
- Create required documents such as reagent manufacturing and quality control testing procedures, incoming material specifications, and performance verifications, and protocols and reports for studies required to transfer reagent products into production
- Assist in or lead investigation and resolution of reagent / consumable-related issues, including assessment of impact, root cause identification, and appropriate corrective and preventive action
- Ensure consistent compliance with applicable regulations and quality-related best practices in development, validation, use, and documentation of assay development, analytical and functional quality control test methods for reagent lot qualification, stability studies, and related activities
- Train and mentor team members in IVD product development and manufacturing transfer
- Perform routine testing of KITE cellular therapy final products and intermediates by qualified/validated analytical methods
- Manage cell culture processes and procedures or cell lines used in analytical assays, Maintain aseptic storage of the MCB and WCB, maintain parallel cell culture trains all the times for testing
- Work with internal and external resources to maintain labs in an optimal state
- Develop, revise and review SOPs, qualification/validation protocols and qualification reports
Qualifications for scientist, quality control
- PhD in Chemistry, Pharmaceutical Science, Chemical Engineering or a related discipline
- Candidates with a minimum of 2 years of relevant Postdoc and/or industry experience coupled with an outstanding record of scientific accomplishments as evidenced by co-authored publications, patents, and/or internal reports may be considered for the Scientist level
- Functional first principle, operational knowledge and/or expertise in quantitative instrumental analysis such as U/HPLC (achiral, chiral, ion, reverse and normal phase), dissolution, gas chromatography, mass spectrometry, SFC and molecular spectroscopy
- Prior supervisory experience is a plus, but not necessary
- Bachelor’s or Associate's degree in a life science or related field
- 2+ years of assay development experience