What are the responsibilities and job description for the Lab Quality Manager position at TriSearch?
Job Description
Job Description
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 states 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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