QA Specialist I (5470)

Senior QA Specialist l, Drug Substance (DS)

Work location: Cranbury, NJ

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

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

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability