Senior QA Batch Record Review Consultant
3 weeks ago
We are seeking an experienced Quality Assurance professional to conduct thorough reviews of batch records, ensuring compliance and quality in pharmaceutical production.
Estimated Salary: $27.00 to $36.00 per hour
About the RoleThis is a unique opportunity to join Entegee, a leading custom automation projects company, specializing in controls and robotic solutions worldwide.
As a Senior QA Batch Record Review Consultant, you will be responsible for:
- Conducting detailed reviews of batch records for compliance with Good Manufacturing Practices (GMP) and regulatory requirements
- Documenting and resolving discrepancies before batch release
- Collaborating with cross-functional teams to ensure quality standards are met
- Providing recommendations for improving batch record documentation and QA processes
- Supporting internal audits and regulatory inspections
- Participating in risk assessments related to batch records
Our benefit offerings provide employees with flexibility to choose coverage that meets their individual needs, including medical, dental, vision, life insurance, short-term disability, and 401K plan.
You may also be eligible for paid leave, holiday pay, and commuter benefits.
RequirementsTo be successful in this role, you should have:
- Extensive knowledge of GMP and FDA, EMA, and other relevant regulatory agencies
- Experience in the pharmaceutical or biotech industry, with familiarity with CAPA processes
At Entegee, we value expertise and collaboration, and we're committed to helping our associates grow and develop their skills.
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