Quality Assurance Specialist
On-site · Pennsauken, New Jersey, United States
Job Summary
Quality Assurance Specialist needed to oversee QA for manufacturing in a GMP-regulated pharma packaging environment. Responsibilities include managing the Quality Management System to maintain ISO 9001 compliance, ensuring controlled documents reflect current practices, handling customer complaints, internal quality notifications, and the CAPA/change control processes, conducting and supporting internal and external audits, and training Internal Auditors. The role requires liaison across operations, supply chain, and engineering to drive quality and compliance while balancing cost, and supporting EHS certifications (14001/45001). Proficiency in English and knowledge of cGMP and ISO standards are essential.
Required Qualifications
- Bachelor’s/Master’s Degree preferred
- 3-5 years of relevant work experience in a QA role
- Fluent in English; customer-facing experience desirable
- Experience with cGMP and ISO 9001/ISO 15378 is preferred
- Knowledge of CAPA, change control, NCRs, and QA documentation
- Ability to train Internal Auditors and prepare for external audits
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