QC Manager, Training
3 weeks ago
Job Description
Job Description
Quality Control Manager, Training & Compliance Allendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues.
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.
REQUIREMENTS
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
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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