Senior QA Specialist l, Drug Substance (DS) Work location: Cranbury, NJ
Responsibilities:- Perform On-The-Floor QA activities pertaining to Drug Substance Manufacturing Operations, including QA observation of Upstream (USP) and Downstream (DSP) processing, real time executed batch record review, corrections, logbook review, room clearance/changeover, and data integrity checks of electronic systems.
- Review, approve, and track executed production records; including client comment resolution.
- Review, approve, and manage deviations, investigations (ensure structured root cause analyses), develop scientifically justified CAPAs, change controls, and complaint records to ensure compliance with cGMP and data integrity expectations.
- Author, revise, and review controlled documents, including SOPs, batch records, protocols, reports, and risk assessments.
- Ensure compliance with applicable SOPs and production requirements.
- Provide QA support during internal audits, customer audits, and FDA inspections by preparing documentation and offering subject matter expertise.
- Support client PIP and client QA during Client visit.
- Attend regular department/global/client meetings as required or assigned.
- Routinely recognizes and resolves Quality Issues on manufacturing floor.
- Seeks management guidance on complex issues.
- Be the primary backup for Associate Director QA Manufacturing for DS Manufacturing.
- Performs duties as requested by management.
- Build and maintain relationships with cross-functional teams including Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues to maintain quality standards.
Qualifications:- Bachelor, Master or PhD degree Biochemistry or other related science discipline
- 8+ years working experience in Drug Substance (DS) Manufacturing or QA in a Biopharmaceutical facility (hands on operational experience for DS manufacturing, either USP or DSP operations, will be highly considered over QA experience only)
- Knowledge of USP and DSP Manufacturing processes
- Knowledge of facility system qualification is desired
- Work is performed in a combination of 80% manufacturing cleanroom and 20% office environment
- Work is generally performed in a clean-room environment generally seated but may require standing and walking for up to 50% of the time.
- Requires working shifts and weekends as needed
- Knowledge of TrackWise and MasterControl is desired.
- Knowledge of FDA and EMA regulations, ICH and cGMP guidelines is a plus
- Knowledge of Biopharmaceutical manufacturing is desired.
- Good Oral and Written communication skills in English
- Good interpersonal communication skills, good organizational skills
Salary ramge for this position is 72,800-116,500
