More jobs:
QA Compliance Specialist
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-01-16
Listing for:
Stark Pharma
Full Time
position Listed on 2026-01-16
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Role Overview
The 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.
Job TitleQA Compliance Specialist
LocationIndianapolis, IN (Onsite)
Experience8+ years
Contract Duration12+ Months
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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×