Job Description

Senior Quality Assurance (QA) Specialist

Position Summary:

We are seeking an experienced Senior QA Specialist to lead quality initiatives and ensure compliance with regulatory standards in a GMP-regulated sterile manufacturing environment. This individual will play a key role in procedure development, investigations, CAPA execution, and audit readiness while supporting manufacturing operations and driving continuous improvement in quality systems.

Key Responsibilities:

• Documentation & Compliance:
• Develop, review, and revise SOPs, work instructions, and training materials in accordance with GMP and FDA guidelines.

• Investigations & CAPAs:
• Lead and approve root cause investigations, corrective and preventive actions, and change control activities in coordination with cross-functional teams.

• Audit & Inspection Readiness:
• Serve as a QA representative during regulatory inspections (e.g., FDA), client audits, and internal audits; ensure timely resolution of observations and findings.
• Complaint & Quality Event Handling:
• Investigate product complaints and quality events to identify root causes and implement effective corrective actions.

• QA Metrics & Reporting:
• Track, analyze, and report on quality metrics to monitor system effectiveness and support continuous improvement efforts.

• Batch Record Review & Product Release:
• Review executed batch records for completeness and compliance; perform final product disposition decisions.

• Supplier & Material Oversight:
• Support supplier qualification, and evaluate/approve incoming materials and components to ensure they meet quality specifications.

• Manufacturing Support:
• Provide on-the-floor QA support for line clearance, equipment compliance checks, and CGMP documentation review.

• Training & Documentation Systems:
• Deliver GMP training and support document control processes within a hybrid QMS (paper/electronic) environment.

• Risk Management:
• Participate in risk assessments and implement mitigation strategies aligned with GMP expectations.

• Continuous Improvement:
• Lead or support initiatives to optimize QA processes and enhance operational efficiency.

• Compliance & Safety Culture:
• Promote a strong culture of compliance, cleanliness, and safety across manufacturing and quality teams.

Qualifications:

• Bachelor’s degree in Biology, Microbiology, Chemistry, or a related field; or equivalent QA experience.

• Minimum 3+ years in Quality Assurance in a GMP-compliant sterile pharmaceutical, biotech, or related environment.

• At least 2 years of experience leading investigations, CAPAs, and audits in an FDA-regulated setting.

• Experience providing QA support on the manufacturing floor, particularly in cleanroom or sterile operations.

• Strong knowledge of FDA regulations (21 CFR Parts 210 and 211) and GMP best practices.

• Proficient in Microsoft Office (Word, Excel); Adobe editing tools a plus.

• Experience working with hybrid QMS platforms (paper and electronic); familiarity with Dot Compliance or similar eQMS preferred.

• Strong communication, collaboration, and problem-solving skills.

• Must be able to work in cleanroom settings and comply with strict gowning and hygiene protocols.

• Must disclose any health conditions that may impact product integrity in aseptic environments.

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