About the Role
The QA/RA Supervisor will be responsible for supporting all FSQR activities related to the USP products and programs at the site level. It serves as a backup to the FSQR Supervisor and FSQR Manager for all applicable areas within Quality and Food Safety to ensure that we satisfy our customers, comply with corporate and local/state/federal legal and regulatory requirements, and continuously improve our systems, processes, and culture.
Key Activities
Ensure compliance with USP specifications, customer, and regulatory requirements at the site.
Support the USP customer complaint investigations process, including conducting root cause analysis and driving corrective action plans, up to and including into manufacturing processes and/or product specification(s).
Support and back up the FSQR Manager during all USP regulatory and customer audits.
Support Quality and Food Safety culture at the site.
Oversees FSQR USP laboratory testing, release and GLP programs.
Support the regular reviews of the facility’s GMP Compliance, Prerequisite Programs, Housekeeping and USP Compliance.
Clear communication with FSQR Manager when facility-related USP incidents occur.
Oversight of USP related instruction, inspection, testing and approval following maintenance and repair work.
Review of COAs for accuracy and distribution as applicable.
Generation, review and revision of USP related SOPs and forms.
Review of USP related work orders.
Assist with new hire and annual USP training.
Calibration and capabilities of USP lab equipment.
Review and identify USP trends, including all USP reporting requirements.
Day to day supervision and scheduling of USP Technicians.
Responsible for coordinating USP testing schedule with operations.
Lead USP validation studies for the site.
Preferred Skills
Supervisory experience preferred.
Strong interpersonal skills, and excellent verbal and written communication skills.
Regularly required to sit or stand, reach, and move about the facility.
Education and Experience
Bachelor’s degree in Chemistry, Biology, Food Science, or other related science field is required.
Minimum of 2 years experience working in a USP / pharma manufacturing environment or quality laboratory.
Strong knowledge of 21CFR 210, 21CFR 211, ICH Q7 or other applicable pharma regulations.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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