Quality Assurance Manager

Responsibilities

• Responsible for the company’s Quality Management System, including 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.

Qualifications

• 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) is 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.