What are the responsibilities and job description for the Quality Lab Manager position at TriSearch?
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 :
