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QC Manager

2 months ago


Markham, Canada Apollo Health and Beauty Care Full time

POSITION SCOPE:

The Quality Control Manager has specific responsibility for ensuring products and the lab environment meet Apollo Health and Beauty Care quality and regulatory standards. This position supports chemists, microbiologists, material sampling, stability, and other laboratory support staff. This position uses their wealth of experience and best practices to support the interest of the company, clients and customers.

RESPONSIBILITIES & DUTIES

Develops, implements, maintains and continually assesses quality control functions against applicable regulatory requirements meeting internal company standards while delivering against customer service levels, including but not limited to the following tasks:

  • Manages a QC team that is comprised of a professional, qualified scientific community capable of ensuring regulatory standards are maintained, including FDA, Health Canada, GLP, GMP and ICH best practices.
  • Planning and directing quality control department programs involving inspection, sampling, QC testing, micro testing, equipment maintenance and calibration, method validation, tech transfer, and analytical methods controls.
  • Ensures timely testing, release, and disposition of all product testing activities.
  • Manages Quality Control resources and licensing requirements to deliver speed to release of materials and products for all OTC, NHP, and Cosmetic products manufactured or sub-contracted by Apollo
  • Development and maintenance of standard operating procedures, work instructions and forms, test methods, calibration documents, test method and lab equipment validation, and equipment manuals supporting the laboratory and quality control systems, while embracing Apollo ‘right first time principles’
  • Oversees the creation and implementation of appropriate quality control training programs and personnel development
  • Contracts, audits and ensures best practices and pricing is maintained for third-party testing laboratories.
  • Manages the OOS/OOT program and uses incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to testing, process and service incidents.
  • Design and monitor KPI’s for all quality control functions focusing on optimization
  • Implements, performs and oversees internal quality control auditing (including applicable vendors or subcontractors), customer quality audit responses and other quality management system activities related to QC testing activities
  • Directs the development and implementation of short-term, long-term strategies, goals, objectives and tactics relating to the quality control function
  • Implements a continuous improvement plan focused on growing and maturing the quality control functions with a focus on periodic internal quality control system reviews and audits
  • Provides direction to resolve identified problem areas and delivers solutions to enhance quality control and prevent future issues
  • Keeps the Vice President of Quality and Compliance and the Senior Leadership Team apprised of any quality control challenges or limitations
  • Acts as a subject matter expert and provides input across other Apollo departments as required
  • Perform other duties as assigned

JOB SPECIFICATIONS:

Knowledge/Education/Experience: 7-10 years progressive experience in practice and leading QC activities in a regulated laboratory environment; Bachelor of Graduate Degree Chemistry or equivalent; industry-recognized licenses and certifications are an asset; experience in leading, coaching, and directing work of others; experience in a variety of the field’s leading concepts, best practices, and procedures; relies on extensive experience and independent judgment to plan and accomplish goals.

Job Types: Full-time, Permanent

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