Sr. Quality Assurance Specialist

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.