QC Manager, Training & Compliance

Quality Control Manager, Training & ComplianceAllendale, 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.