Kelly® Science & Clinical is seeking a QA Coordinator for a temp-to-hire position at a premier Supplement and Nutraceutical Contract Manufacturing Organization (CMO) in Ogden, UT. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule:
Monday-Friday, standard working hours
Responsibilities:
Oversee the organization and upkeep of various records, including SOPs (with periodic revisions), calibrations, complaints, internal/external audits, vendor and supplier reviews, corrective actions, non-conformances, facility and equipment modifications, IQOQPQ, logbooks, forms, HACCP plans, and other controlled materials.
Manage both physical and digital document control systems, assign unique document identifiers, issue and distribute finalized documents, monitor physical copies, and maintain logs in accordance with company regulations and external guidelines.
Facilitate onboarding for new team members under cGMP standards, develop and administer relevant tests, assign role-specific learning paths, deliver annual training sessions for cGMP and food safety, and track progress through a learning matrix.
Provide support and guidance to employees on quality issues, ensuring regulatory adherence and compliance.
Manage daily document updates, ensuring changes are processed quickly and communicate any updates to the affected departments prior to implementation.
Lead investigations into product complaints, manage customer responses, ensure closure within a specific timeframe, track corrective actions (CAPAs) and supplier corrective actions (SCARs), and maintain associated logs.
Review and document calibration data and assist the maintenance team with updating the calibration schedule in the maintenance software.
Conduct internal audits of the QMS, manage annual customer certification processes, and ensure preparation for third-party and regulatory inspections.
Compile audit reports, verify corrective action effectiveness, and provide KPIs on internal audits.
Assist with FDA recall/withdrawal procedures by conducting research, submitting documentation, conducting follow-up checks, and keeping CAPA, FDA, and customers updated.
Track and report KPIs related to complaints, CAPAs, audit performance, changes, and training activities.
Ensure adherence to FDA's Foreign Supplier Verification Program (FSVP) under FSMA by working with procurement to gather food safety documentation.
Prioritize assignments in fast-paced, deadline-driven situations, and complete necessary documentation for pre-audit forms, GMP certifications, licenses, and contract customer registrations.
Perform other duties as assigned
Qualifications:
High School Diploma. Bachelor's degree in Food Science, Chemistry, Biology, or Life Science preferred
3+ years of experience in quality assurance within industries governed by 21 CFR Parts 111, 117, and 210/211.