POSITION DESCRIPTION:
The Quality Manager will be responsible for strategic development and leadership of the QS Management System within a GMP and GLP environment, as well as adhere to OSHA and other state/industry regulations through policies and training for technical and operational staff.
ESSENTIAL FUNCTIONS:
• Improve and ensure Quality Management Systems in compliance with GMP, GLP, and regulatory certifications (USDA, FDA 21 CFR, ISO/IEC 17025).
• Conduct internal audits to identify quality problems and improve operational processes.
• Coordinate and support on-site audits or inspections
• Conduct risk assessments and develop plans for remediation to mitigate risk.
• Monitor CAPAs and change control requests.
• Manage customer complaint process and ensure effectiveness of customer deliverables.
• Support Quality group with department strategy development, objectives and goal setting, project prioritization activities.
• Ensure all activities are performed in accordance and in compliance with Code of Ethics, Quality Assurance, and Health & Safety policies
• Interface with all technical departments to ensure compliance to all quality standards, including the qualification of personnel to quality and safety policies and procedures.
• Identify training needs and organize training interventions to meet quality standards.
• Draft, maintain, and disseminate policies and procedures.
• Ensure compliance to Health & Safety policies and procedures and instill a safety-first culture. Generate accident reporting and trend analysis.
• Ensure compliance to the state’s hazardous waste management requirement.
• Coordinate and authorize verification and validation activities in accordance with GLP, AOAC, or FDA standards.
• Review documents and records for accuracy and technical application of standards.
Qualifications/Requirements:
• BA or BS degree in Chemistry or Health & Safety, plus a minimum of 5-7 years’ management or supervisory experience. CSP an asset.
• Experience working in a Chemistry, Biochemistry, Microbiology, or Quality driven environment is preferred.
• Solid understanding of Regulations and Standards for both GMP/GLP and OSHA.
• Understanding of compendial test methods (USP, FDA, ISO, ASTM, AOAC)
• Strong leadership, communication, and technical writing skills.
• Demonstrated ability to coach and train others.
• Certified in audit processes.
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