Batch Record Review

Summary: Seeking an experienced QA Batch Record Review Consultant to ensure compliance and quality in pharmaceutical production.

Job Requirements:

• Extensive knowledge of Good Manufacturing Practices (GMP)

• Experience with FDA, EMA, and other relevant regulatory agencies

Preferred Skills:

• Pharmaceutical or biotech industry experience

• Familiarity with CAPA processes

Job Responsibilities:

• Conduct detailed reviews of batch records for compliance

• Document and resolve discrepancies before batch release

• Collaborate with cross-functional teams to meet quality standards

• Provide recommendations for improving batch record documentation

• Assist in the development of QA processes and procedures

• Support internal audits and regulatory inspections

• Participate in risk assessments related to batch records

• Train teams on best practices for documentation and review

Pay Details: $27.00 to $36.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.