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Quality Control Manager, Microbiology and Sample Management
2 months ago
We are seeking a highly experienced Quality Control Manager, Microbiology and Sample Management to join our team at Iovance Biotherapeutics, Inc. This is a challenging and rewarding role that requires a strong background in microbiology, quality control, and leadership.
Key Responsibilities- Manage and oversee the day-to-day operations of the Quality Control Microbiology laboratory, ensuring compliance with regulatory requirements and company policies.
- Lead investigations into out-of-specification test results and implement corrective actions to prevent recurrence.
- Develop and implement quality control procedures, protocols, and training programs to ensure the accuracy and reliability of test results.
- Collaborate with cross-functional teams, including research and development, manufacturing, and quality assurance, to ensure seamless integration of quality control activities.
- Develop and maintain relationships with external partners, including vendors and regulatory agencies, to ensure compliance with regulatory requirements.
- Stay up-to-date with industry trends, regulatory requirements, and best practices in quality control and microbiology.
- Bachelor's degree in a relevant discipline, such as microbiology, biology, or chemistry.
- Minimum 8 years of experience in quality control, microbiology, or a related field, with at least 3 years of leadership experience.
- Strong knowledge of regulatory requirements, including cGMP and ISO 13485.
- Excellent communication, leadership, and problem-solving skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
- Experience with cell therapy products and processes.
- Knowledge of quality management systems, such as ISO 9001.
This position will work in a laboratory setting, with exposure to various chemical and biochemical agents. The ideal candidate will be able to work in a cleanroom environment and wear personal protective equipment as required.
