Quality Assurance Specialist - 164199

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 Companiesis currently looking for an experiencedQuality Assurance SpecialistinAudubon, Pennsylvania(PA) to work for pharmaceutical manufacturer.

Responsibilities for the Quality Assurance Specialist include:

• Revie 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

Qualifications for the Quality Assurance Specialist include:

• A minimum of 1-5 years’ experience within Pharmaceutical Manufacturing
• Hands on experience with Batch Record review
• Proficiency in Microsoft Office
• B.S. in business or scientific field preferred

Compensation for the Quality Assurance Specialist include:

• Salary Range is $65,000-$72,800 dependent upon experience.
• Comprehensive benefits package

Keywords

Quality Assurance Associate, QA, Pharmaceutical, Audubon, PA, Pennsylvania, FDA, GMP, Batch Record, Manufacturing, GDP, cGMP, Clinical Manufacturing, Regulatory Review #LI-ONSITE #LI-DF1