QA Specialist I

Job Title – QA Specialist

Work Location – Cranbury, NJ

Job Summary:

We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and company standards, focusing on material release processes, documentation, and training.

Job Responsibilities:

• Leverage WuXi Biologics global quality systems and collaborate with cross functional teams to maintain Quality Management Systems (QMS) including but not limited to SOPs, Document Control, Product complaints, training, change management, deviation management, CAPA and internal audit programs
• Assist with clinical and commercial batch disposition: thorough review of QC documents, executed batch records, associated laboratory investigation reports (LIRs), deviations, impact assessments, change controls and other quality systems to determine acceptability of final batch product quality and disposition
• Support with the development, implementation and continuous monitoring key performance and quality indicators, metrics/dashboards to assess QMS effectiveness periodically.
• Identify gaps/deficiencies in site QMS and assist with remediation efforts and progress.
• Promote a quality mindset across functional departments to ensure consistent, science and technology based, risk averse decision-making process.
• Assist with client audits/regulatory inspection process.
• Support internal audit programs and process improvement for quality systems.
• Ensure timely and effective quality support of commitments to clients/corporate.
• Review and approve verification/qualification/validation documentation and lifecycle documentation, including User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ)/Reports, User Acceptance testing, traceability matrix, system, Validation Plans/Reports, SOPs, Change Control Documentation, and Risk Assessment Reports, etc.
• Perform electronic data review of IPC testing, release testing and stability.
• Conduct LIMS review of IPC, release and stability data.
• Conduct and/or review event and deviation investigations, OOS/OOT investigations, change controls and CAPAs.
• Follow SOPs to perform routine activities such as periodic reviews, account audit, data integrity audit, etc.
  
  
  
  

Qualifications:

• Bachelor's degree in a relevant field (Pharmaceutical Sciences, Chemistry, etc.) Proven experience in a QA role, preferably in a GxP-regulated environment Strong knowledge of regulatory requirements and industry standards Excellent analytical, problem-solving, and communication skills Ability to work independently and prioritize tasks effectively
  
  
  
  

The anticipated salary range for this position is $60,200-96,300

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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