Scientist II (QC Data Reviewer)
Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: January 15, 2022
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
- 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
- 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
- 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
- Ensures data integrity practices and procedures are implemented
in QC and adhered to for quality compliance and to meet industry
- 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
- Participation in regulatory, internal and client audits
- Carries out duties in compliance with all local, state and
federal regulations and guidelines including FDA, EPA, and
- 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
- 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
- Routine use of MS Excel, MS PowerPoint, and MS Word is
- 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
- Technically competent, and thorough knowledge of scientific
principles pertaining to analytical and microbiological data being
- 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
- 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! http://jobs.thermofisher.com
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
Keywords: Thermo Fisher Scientific, St. Louis , Scientist II (QC Data Reviewer), Other , Saint Louis, Missouri
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