QA Specialist - Pharma Batch Records & Compliance

ZP Group; Lower Providence Township (PA); On-site; USD 65,000 - 73,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking an experienced Quality Assurance Specialist in Audubon, Pennsylvania to join a pharmaceutical manufacturing team. The role emphasizes batch record review, documentation accuracy, and regulatory compliance.

Responsibilities include advising manufacturing personnel, correcting documentation, and assisting in Deviation/OOS investigations, with a strong focus on FDA and cGMP standards.

Qualifications

• Hands-on experience with Batch Record review.
• Strong familiarity with FDA and GMP regulations.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

Responsibilities

• Review batch records and documentation for completeness and accuracy in preparation for batch release.
• Correct and revise documentation as needed.
• Advise manufacturing personnel on proper documentation.
• Utilize knowledge of FDA and GMP regulations to ensure compliance.
• Assist in Deviation/OOS investigations.

Skills

Batch Record review

FDA and GMP regulations knowledge

Education

B.S. in business or scientific field preferred

Tools

Microsoft Office

Job description

Piper Companies is seeking an experienced Quality Assurance Specialist in Audubon, Pennsylvania to join a pharmaceutical manufacturing team. The role emphasizes batch record review, documentation accuracy, and regulatory compliance.

Responsibilities include advising manufacturing personnel, correcting documentation, and assisting in Deviation/OOS investigations, with a strong focus on FDA and cGMP standards.