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.

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.

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