Quality Assurance Manager, Batch Review
Location: Kansas
Work Situation: On-site
A mid-size pharmaceutical company is seeking a highly skilled and experienced Quality Assurance Manager to join our team. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with specific expertise in batch record management, batch release, batch review, lot release, and product release.
The QA Manager will have the following responsibilities...
- Oversee the creation, review, and approval of batch production records to ensure compliance with regulatory requirements and internal procedures.
- Review batch documentation and analytical data to verify compliance with specifications and regulatory requirements prior to release.
- Conduct thorough reviews of batch documentation, including production records, laboratory testing results, and deviation reports, to identify any discrepancies or quality issues.
- Collaborate with cross-functional teams to investigate and resolve batch-related deviations or non-conformances.
- Ensure that all necessary quality checks and inspections are completed prior to lot release, in compliance with regulatory requirements.
- Oversee the final release of products for distribution, ensuring that all regulatory and quality requirements are met.
- Maintain accurate records of product release activities and documentation for auditing purposes.
- Implement and maintain effective quality systems and procedures to support batch record management, batch release, and product release activities.
- Continuously evaluate and improve quality processes to enhance efficiency and compliance.
The QA Manager should have the following qualifications...
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree preferred.
- Minimum of 5 years of experience in quality assurance roles within the pharmaceutical industry, with a focus on batch record management and batch release.
- In-depth knowledge of cGMP regulations, FDA guidelines, and other relevant regulatory requirements.
- Strong analytical and problem-solving skills, with the ability to effectively investigate and resolve quality issues.
- Prior experience managing quality systems and implementing process improvements is highly desirable.
- Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor) is a plus.
Benefits:
- 401k
- Competitive Salary
- Insurance
- Relocation assistance
