Quality Assurance ManagerKelly Science, Engineering, Technology & Telecom • Jackson, Mississippi, United States
Quality Assurance Manager
Kelly Science, Engineering, Technology & Telecom
- Jackson, Mississippi, United States
- Jackson, Mississippi, United States
Über
SUMMARY The QA Manager will oversee all quality assurance activities at a pharmaceutical distribution and repackaging facility in Taylor, MS, ensuring strict compliance with FDA regulations (21 CFR 210/211, ICH Q7) and GMP standards. This role is responsible for vendor qualification, inventory, and warehouse QA processes, including investigations, deviations, and supply chain oversight, with direct reports and extensive cross-functional collaboration. The ideal candidate brings at least 10 years of QA experience (5+ in a supervisory role), excellent communication skills, and the ability to support business growth in a dynamic, fully onsite environment. 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 regulated GMP manufacturing and distribution environment. * Experience in ICH Q7, 21 CFR Part 11, 21 CFR 210 and 211 * 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. * ASQC quality certifications, ISO 9000 or other Audit training preferred.
* Send Resumes to Jacqueline.Sayoc@KellyScientific.com
Sprachkenntnisse
- English
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