QC Manager, Training & Compliance

Job Description

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 abilitiesWhile 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.