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.