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QA Compliance Specialist
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-01-12
Listing for:
Stark Pharma
Full Time
position Listed on 2026-01-12
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Job Title: QA Compliance Specialist
Location: Indianapolis, IN (Onsite)
Experience: 8+ years
Contract Duration: 12+ Months
Role OverviewThe QA Compliance Specialist will support and maintain Quality Systems within a GMP-regulated biopharmaceutical manufacturing environment. This role focuses on ensuring inspection readiness, driving compliance initiatives, supporting regulatory activities, and strengthening quality governance across operations.
Key Responsibilities- Support and implement Quality Systems in alignment with cGMP, FDA, ICH, and EU regulatory requirements
- Lead and support Quality Management Review activities, including metrics tracking and reporting
- Ensure ongoing inspection readiness and participate in regulatory inspections and audits
- Manage QA compliance programs, including internal audits and self‑inspections
- Review, approve, and support investigations, deviations, CAPAs, and change controls
- Ensure data integrity compliance in accordance with ALCOA+ principles
- Author, review, and approve SOPs, policies, and quality documentation
- Provide QA guidance to cross-functional teams on compliance-related matters
- Support regulatory submissions, responses, and commitments as needed
- Identify compliance gaps and drive continuous quality improvement initiatives
- Bachelor's degree in Life Sciences or a related discipline
- 8+ years of experience in a GMP biopharmaceutical manufacturing environment
- Minimum 2+ years of hands‑on Quality Assurance experience
- Strong working knowledge of cGMP, FDA, ICH, and EU regulations
- Proven experience with QA compliance programs and inspection readiness
- Solid understanding of data integrity principles, including ALCOA+
- Experience conducting or supporting self‑inspections and internal audits
- Strong SOP authoring, reviewing, and document control experience
- Ability to work onsite and collaborate effectively with cross‑functional teams
- Experience supporting radiopharmaceutical or sterile manufacturing operations
- Prior involvement in regulatory agency inspections
- Strong communication, documentation, and problem‑solving skills
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