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.
...following mission critical / critical infrastructure equipment: G enerators, Automatic Transfer Switch, Uninterruptable Power Supply (UPS), Computer Room Air Conditioners (CRACs), DC plants, Power Distribution Units (PDU), Battery Cabinets and other critical equipment....
...various tasks, duties, and responsibilities commonly carried out by HVAC Construction Installers are highlighted in the job description... ...brazing and soldering. Perform installation of flex and sheet metal duct systems in light commercial and residential buildings....
...you will use echocardiograms to take images of patients' hearts. Working in a hospital, outpatient center, private practice, imaging... ...short-term assignments are available. Want to work close to home? We have plenty of local opportunities as well. You could even work...
...Shift First (Days) (United States of America) Sentara Regional Resource Pool located in Hampton Roads is hiring an Inpatient Case Manager, MSW -Days/Flexi for the Resource Pool. Required to work 4 hospitals in the Southside or Western Tidewater regions. Location...
Supervises and coordinates daily activities of employees to ensure safe and effective operations. Monitors and enforces safe working habits in accordance with OSHA/ TSA/ DOT/ USPS regulations, Unifi policies and safety procedures, and all applicable Customer Service, Supervisor...