Senior QA Specialist

Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth With 2 commercial products already on the market and a third approval expected any day, they’re expanding and renovating their New Jersey facility to scale up production from 50L to 2000L. We’re kicking things off by rapidly expanding their quality team with the hire of a Senior QA Specialist. The appointed candidate will support the activities of the QA department in review of QC data and reports, and other reports such as SOPs, CAPAs, Deviations, Change Controls and OOS as needed. Requirements: Writes, revises, and reviews standard operating procedures (SOPs). Conduct reviews of release testing, stability testing, raw material testing, method validations, equipment qualifications and calibrations, technical protocols and reports to ensure compliance with internal procedures and policies, good documentation practices (GDPs), current good manufacturing practices (cGMP), ICH, and other applicable regulations. Provide assurance that documentation and testing comply with internal procedures, specifications and cGMP regulations prior to generation of COA for product release. Reviews and provides input on lab investigations, deviations, and CAPAs. Coordinates with lab analysts to resolve documentation or quality issues and implement corrective or preventive actions as necessary. Interfaces with other testing laboratories as needed. Implements and manages systems related to document management and control. Provides ideas to drive efficiency. Coordinates projects and activities with other staff/departments, assures task completion. Has familiarity with FDA guidelines for biosimilars, USP, GLP, cGMP, Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines, ICH guidelines, and SOPs. Assures that laboratory personnel are following all company SOPs and safety rules. Assists with or manages samples for QA retains, stability, or transport to other sites. Assures that test batch records and deviations, OOS results, QA audits, and other paperwork are completed according to cGMPs and company SOPs. Experience/Qualifications: A BSc degree at minimum in a life science field. Previous laboratory experience as an analyst/scientist is preferable. Previous experience (3 to 4 years) in cGMP pharmaceutical manufacturing environment is required. Working knowledge of cGMP regulation is required. In-depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation. If you’re interested, please apply below. J-18808-Ljbffr