Job Opportunity

Job Opportunity

Senior Specialist I, Quality Assurance - DP

Senior Specialist I, Quality Assurance - DP

United States Posted 2024-10-21

Senior Specialist l, QA - DP

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:

Build and maintain relationships with cross-functional teams including Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues to maintain quality standards.
Perform QA activities on shop floor focused on Manufacturing Operations, including QA observation of Product Fills and Media Fills, AQL Visual Inspection of filled vials and syringes, real-time executed batch record review, corrections, logbook review, room clearance/changeover, and data integrity checks of electronic systems.
Ensure compliance with applicable SOPs and production requirements.
Support client PIP and client QA during Client visit.
Attends the Quality Events on the floor as the initial quality contact and communicates the event with DPQA team.
Attends 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 DPQA Manager and be the DPQA Lead.
Performs duties as requested by DPQA Manager.

Qualifications:

Bachelor, Master or PhD degree Biochemistry or other related science discipline
8+ years working experience as Manufacturing or QA in a Biopharmaceutical facility
Knowledge of Aseptic Filling and Visual Inspection is required
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

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

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