Quality Assurance Specialist

Piper Companies; Ridgefield (NJ); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking an experienced Quality Assurance Specialist in Ridgefield, New Jersey to support a growing pharmaceutical manufacturer. The role focuses on reviewing electronic batch records, ensuring completeness and accuracy, and advising manufacturing teams on proper documentation.

Candidate requirements include 1–5 years in pharmaceutical manufacturing (sterile injectable preferred) and experience with batch record review.

Qualifications

• 1-5 years’ experience in Pharmaceutical Manufacturing (sterile injectable preferred).
• Hands-on batch record review experience.
• Proficiency with Microsoft Office.
• B.S. in business or scientific field preferred.

Responsibilities

• Review commercial electronic batch records and documentation for completeness and accuracy prior to batch release.
• Correct and revise documentation as needed.
• Advise manufacturing personnel on proper documentation.
• Apply knowledge of FDA and GMP regulations to ensure compliance.
• Conduct investigations for Deviation/OOS.

Skills

Batch record review

Documentation review

Attention to detail

Education

B.S. in business or scientific field

Tools

Microsoft Office

Job description

Piper Companies

We are currently looking for an experienced Quality Assurance Specialist in Ridgefield, New Jersey (NJ) to work for an innovative and growing pharmaceutical manufacturer.

Responsibilities

• Review commercial electronic 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
• Conduct in Deviation/OOS investigations

Qualifications

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

Compensation

• Salary Range is dependent upon experience.
• Comprehensive benefits package