QC Scientist III
1 month ago
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 ( 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
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