Manager, Quality Assurance

RESPONSIBILITIES:

• Supervise the daily activities in the warehouse to ensure efficient flow of materials and timely completion of Quality Assurance duties.
• General oversight of systems for labeling, GMP training, compliance, document control, information tracking, and equipment calibration.
• Lead investigation activities perform root-cause analyses and develop corrective and preventative action plans.
• Assist in internal and external audits and inspections.
• Develop and maintain appropriate document storage and retrieval systems.
• Assist with the review and approval for original and/or revised Quality Operation Processes, and GMP documentation.
• Use of statistical process control to evaluate trends and provide periodic KPI trend reports to senior management as required.
• Assure timely closure of audit items.
• Provide reports from QA and data to support other business functions, as needed.
• Ensure Deviations, CAPA and Change Controls are managed in a timely manner.
• Support the customer complaint process and respond to Customer complaints as required.
• Performs other related duties as required.
• Supervise and mentor junior staff members and other related duties as required.
• Comply with cGMP regulations and all standard operating procedures.

QUALIFICATIONS:

• Bachelor's degree in a scientific discipline.
• 10+ years of experience in Quality Assurance in a GMP regulated manufacturing environment, or equivalent combination of education and experience.
• 5+ years of experience leading or supervising others in a GMP regulated manufacturing and distribution environment preferred.
• Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations.
• Strong communication skills, both written and verbal.
• Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
• Strong attention to detail.
• Experience in ICH Q7, 21 CFR Part 11, 21 CFR 210 and 211
• ASQC quality certifications, ISO 9000 or other Audit training preferred.