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Manager Quality Operations Jobs
Company | Charles River Laboratories |
Address | Memphis, TN, United States |
Employment type | CONTRACTOR |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-25 |
Posted at | 10 months ago |
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
- Provide support of quality systems activities.
- Responsible for ensuring that project goals and objectives are met.
- Provide oversight for On the Floor Quality activities for batch release of raw materials and GMP manufacturing.
- Review GMP investigations of product specific deviations, OOS, OOT and corrective actions to ensure compliance
- Responsible for ensuring the release of Raw Materials based on Client specifications and regulatory standards.
- Develop training materials to ensure that Quality Operations employees meet the requirements of the company and clients.
- Ensure all release data, investigations and change controls related to Cell Therapy manufacturing and facility operation are documented and complete.
- Develop strategies to create an environment of continuous improvement.
- Perform failure analysis, risk assessment and mitigation as related to GMP facility operations.
- Work collaboratively with the Manufacturing, Quality Systems, Quality Control, Project Management, Facilities, and Supply Chain units to meet company and client goals.
- Lead, develop, and mentor a team of Quality Operations employees.
- Oversee the review and approval of production batch records, specifications, and lab data.
- Support client and regulatory audits, as well as internal corporate audits.
- Ability to communicate and work independently with scientific/technical personnel
- Excellent interpersonal, verbal, and written communication skills are meaningful in this collaborative work environment
- Experience in Gene Therapy preferred
- Proactive, detail-oriented, and comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
- Solid understanding of Deviation, CAPA, Change Control, Auditing practices/strategies
- Strong analytical, problem-solving, and project management skills.
- Experience reviewing and releasing Final Product preferred
- 7+ years of Quality Assurance experience in a GXP related field within the biotechnology, biologics, or pharmaceutical industry
- BS or higher degree in scientific or relevant engineering discipline
- Strong knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations
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