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.