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QC Manager, Training
2 months ago
- Develop and maintain training program within Quality Control which includes, onboarding and continuous training
- Manage deviations, CAPAs, change controls and document review to ensure compliance
- Ensure OOS investigations are completed adequately.
- Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories
- Identify resources needed for training and compliance and build team accordingly
- Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements.
- Monitor effectiveness of CAPAs, change control activities, and audit observation closure.
- Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators
- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions.
- BA/BS/MS in a science or relevant field required
- Prior cGMP experience required
- Prior QC laboratory experience in a cGMP environment a must
- 3-5 years’ experience in the pharmaceutical, biologics ore related industry
- Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position
- Sound understanding of cGMPs
- Experience in laboratory training and compliance
- External laboratory management experience
- Strong knowledge of testing methodologies, philosophies, method validation and method transfers.
- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
- Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner
- Experience with laboratory training programs
- Knowledge of GMP requirements
- Excellent organizational and leadership skills
- Outstanding analytical problem-solving abilities
