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Scientist II (QC Data Reviewer)

Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: January 15, 2022

Job Description:

Scientist II (QC Data Reviewer)

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information
St. Louis / QC Biologics

How will you make an impact?

The Scientist II (Data Reviewer) will be responsible for data review of Raw Material testing, microbiological and analytical testing and data generated in the Quality Control department in support of Commercial and Clinical Biopharmaceutical Manufacturing. The person will be responsible for following Current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to Data Review and Laboratory Data Integrity Compliance activities as mandated by Corporate Standards.

What will you do?

  • Perform microbiological and complex analytical data review, including review of audit trails, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.
  • Performs compendial testing data review, including review of audit trails, evaluating laboratory data for compliance with USP, EP, JP and other compendia.
  • Performs analytical data review of method qualification and validation interpreting data for compliance with protocol and technical soundness
  • Reviews sample results for completeness and accurate representation of the data and report findings, including proper and correct entry in LIMS and control trending
  • Communicates with laboratory staff to proactively address the quality of laboratory documentation
  • Notes deficiencies with the microbiology or analytical data set, HRF or notebooks, and ensures that all valid deficiencies are corrected by the analysts. Reports deficiencies and escalates concerns to management.
  • Attends training sessions for method and protocol training, and ensures that training record is present for every SOP, TM or protocol executed
  • Requests training if work assigned requires knowledge of SOP, protocol or method with no record of training or reads and asks questions about SOPs, TM, protocols in training.
  • Reviews Certificate of Testing, Specifications, and inputs data in PIMS
  • Ensures data integrity practices and procedures are implemented in QC and adhered to for quality compliance and to meet industry standard.
  • Generates metrics to capture Right First Time and On Time Delivery for reviewing microbiological, wet chemistry and analytical data packets
  • Identifies, participates in, and sometimes leads operational improvement initiatives
  • Participation in regulatory, internal and client audits needed
  • Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
  • Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
  • Performs other duties as assignedHow will you get here?
    Bachelor's Degree in a Biological Science (preferably Chemistry, Biochemistry) related field and 3+ years related experience in biopharmaceutical or pharmaceutical industry.
    • Extensive knowledge of GMP regulations in cGMP manufacturing environment.
    • At least 3 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company.Knowledge, Skills, Abilities
      • Working knowledge of cGMPs and Quality Control regulatory requirements
      • Routine use of MS Excel, MS PowerPoint, and MS Word is essential
      • Extensive knowledge of scientific principles for wide range of analytical techniques (Chromatography, Capillary Gel Electrophoresis, DNA, Spectrophotometry, ELISA, Cell Based Assay), microbiological techniques (Bioburden, Endotoxin) and wet chemistry (testing per USP, EP, JP and other pharmacopoeia)
      • Ability to critically evaluate and review almost all test records generated independently
      • Comfortable with electronic systems (LIMS) and laboratory equipment (e.g. chromatography, PA800, Plate readers, etc) to be able to perform audit trail of testing records
      • Ability and willingness to learn new instrumentation and/or method/procedure as required, and follows direction from management including priorities
      • Technically competent, and thorough knowledge of scientific principles pertaining to analytical and microbiological data being reviewed
      • Proven time management skills, highly organized with attention to detail and a questioning attitude
        • Excellent verbal and written communication skills
        • Ability to work in a collaborative team environment
        • Ability to learn quickly in a rapidly changing and challenging environment
        • Ability to deal with multiple and changing priorities
        • Performs analytical and technical troubleshooting
          At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

          Apply today!

          Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, St. Louis , Scientist II (QC Data Reviewer), Other , Saint Louis, Missouri

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