QA Specialist – Pharmaceutical Manufacturing

Job Summary:

Seeking a QA Specialist with pharmaceutical manufacturing experience to support quality operations, commissioning and qualification (C&Q), CAPA investigations, batch record review, and batch disposition. The specialist will work with cross-functional teams to maintain cGMP compliance, resolve quality issues, and support inspection readiness.

Key Responsibilities:

• Provide QA support for pharmaceutical manufacturing operations in accordance with cGMP and approved procedures.
• Review C&Q documentation for equipment, utilities, and manufacturing systems.
• Participate in CAPA investigations, root cause analysis, corrective action implementation, and effectiveness checks.
• Review batch manufacturing records and supporting documentation for completeness, accuracy, and compliance.
• Support batch disposition by verifying that required records, investigations, and quality requirements are addressed before release.
• Investigate deviations, discrepancies, and nonconformances and support timely resolution.
• Collaborate with Manufacturing, Engineering, Validation, and Quality Control to resolve compliance and documentation gaps.
• Maintain accurate quality records and support audits and inspection readiness.

Required Qualifications:

• Quality Assurance experience in the pharmaceutical industry.
• Hands-on experience supporting commissioning and qualification (C&Q) activities.
• Experience with CAPA, deviation investigations, and root cause analysis.
• Experience reviewing batch records and supporting batch disposition.
• Strong knowledge of cGMP, pharmaceutical quality systems, and documentation practices.
• Strong technical writing, investigation, organizational, and communication skills.