Quality Assurance Manager
- Responsible for company’s Quality Management System, to include ISO 9001 and 17025.
- Responsible for processing audit CAPAs, including effectiveness checks through closure. Perform all appropriate follow up activities to ensure CAPA closure within a timely manner.
- Prepare Key Performance Indicator reports and present status in review meetings.
- Plan and coordinate quality assurance programs and develop quality control policies.
- Maintain Standard Operating Procedures (SOPs) and ensure their compliance to ISO 9001/17025 requirements and the business’s policies.
- Audit existing procedures and revise as needed and implement through training.
- Understand and monitor all operations that affect quality, perform gap analysis, and devise and implement improvement plans.
- Conducts audits of suppliers as needed.
- Keep abreast of the ISO changes & enhancements and educate the business on compliance requirements.
- Working knowledge of ISO 9001 and 17025 Quality Procedures.
- Recent experience facilitating ISO 9001 and 17025 audits.
- Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written form.
- Experience with current Good Manufacturing Practices (cGMP) a plus.
- Experience integrating acquired companies into an ISO certified organization.
- Bachelor’s degree in science (chemistry, analytical chemistry biochemistry, biotechnology or similar) or equivalent lab experience
- Knowledge of lab practices, standard concepts, and test procedures for analytical instruments
- In depth knowledge of Quality System Processes
- MS office skills required.
- Ability to lift 50 pounds.
- A valid driver’s license in good standing is mandatory.