Job DescriptionWhen 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 InformationThis position supports the QC team for our Biologics Division in St. Louis, MO.How will you make an impact?The Scientist III (Data Reviewer) will be tasked with review of Raw Material, microbiological and analytical testing and data generated in the Quality Control department in support of Commercial and Clinical Biopharmaceutical Manufacturing. The person will follow Current Good Manufacturing Practices (cGMP) and carry 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 review of laboratory generated data for compliance to analytical methods, SOPs, directives and scientific soundness including audit trails.
Performs analytical data review of method qualification and validation interpreting results for compliance with protocol and technical soundness
Reviews sample results for completeness and accurate representation of the data and report findings, including accurate entry in LIMS and control trending systems
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 raises concerns to management.
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 on Right First Time and On Time Delivery
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.
Follows all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
How will you get here?
Bachelor’s Degree in a Biological Science (preferably Chemistry, Biochemistry) related field and 7+ years related experience in biopharmaceutical or pharmaceutical industry.
Confirmed understanding of GMP regulations in cGMP manufacturing environment.
Knowledge, Skills, Abilities
Shown understanding of cGMPs and Quality Control regulatory requirements
Routine use of MS Excel, MS PowerPoint, and MS Word is needed
Scientific knowledge for wide range of analytical techniques (Chromatography, Capillary Gel Electrophoresis, DNA, Spectrophotometry, ELISA, Cell Based Assay), microbiological techniques (Bioburden, Endotoxin) and wet chemistry
Ability to critically evaluate and review almost all test records generated independently
Proficiency with electronic systems (LIMS) and laboratory equipment (e.g. chromatography, PA800, Plate readers, etc) to be able to perform audit trail of testing records
Technically proficient, and detailed knowledge of scientific principles pertaining to data being reviewed
Shown time management skills, highly organized with attention to detail and a questioning demeanor
Excellent verbal and written communication skills
Ability to work both independently and in a collaborative team setting
Ability to learn quickly in an evolving and sophisticated environment
Ability to handle multiple and changing priorities
Performs analytical and technical troubleshooting in collaboration with testing teams
Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!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.