Job Opportunity

Job Opportunity

Associate Specialist, Quality Assurance

Associate Specialist, Quality Assurance

United States Posted 2024-07-30

Associate Specialist, Quality Assurance

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 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 DSQA 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.
Performs duties as requested by DSQA Lead.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents
Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Supervisor.
Adherence to the WuXi corporate core values and PROUD culture

Qualifications:

0-2 years working experience as Manufacturing or QA in a Biopharmaceutical facility
Good Oral and Written communication skills in English
Knowledge of FDA and EMA regulations, ICH and cGMP guidelines is a plus
Good interpersonal communication skills, good organizational skills
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
Bachelor, Master or PhD degree Biochemistry or other related science discipline

Knowledge / Skills / Abilities:

Knowledge of TrackWise and MasterControl is desired.
Knowledge of Biopharmaceutical manufacturing is highly desired

WuXi Biologics is 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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