Description · Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.) · Perform raw data review of third-party release and stability testing data · Perform trending for release, and stability using applicable software (JMP, iStability, Graphpad, etc). · Draft and review QC documentation including Stability Protocols and Reports, SOP’s, Material specifications, CoA templates and other quality documents. · In collaboration with Analytical Development, support method qualification, fit for use, validation and method transfer activities · Support reference standard program · Draft and execute quality systems (e.g., OOS/OOT, Deviations, Change Controls and CAPA’s) Additional responsibilities and ad hoc projects as required Education · BS with 5 years+ industry experience required · 3+ years of quality control related experience · Experience working in QC lab environment with knowledge of international and national regulations and guidelines related to product testing, familiarity with ICH analytical and stability requirements · Experience with EDMS systems (Veeva, Mastercontrol, ZenQMS, etc) and LIMS (Labware, Labvantage, etc) a plus · Excellent communication skills and ability to build key networks and business relationships across all levels of the business · Experience in method transfer, validation, qualification a plus · Lab experience in release and stability testing a plus Experience Drafting, Reviewing and performing data verification of regulatory filing sections. Job Type: Full-time Pay: $60.00 - $68.00 per hour Expected hours: 40 per week Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance Schedule: Monday to Friday Work Location: In person