QA Lab Manager

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13702329 ## Who We Are Since 1990, weve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. Were passionate, science-driven, and always looking for new ways to improve lives. Explore your future atFagron Career Site. ## About The Job [The Quality Assurance Manager will establish and lead the on-site Quality Unit for Fagron Analytical Services. This position owns the quality systems, data review, and disposition of laboratory testing at FAS and is independent of laboratory operations under 21 CFR 211.22.]{contrast="auto"} [The Quality Assurance Manager has the authority to approve or reject procedures, methods, results, investigations, and dispositions. This position reports to the Quality Leader, FSS North America, serves as the primary liaison to Chemistry, Microbiology, Sample Administration, and other functional areas within FAS, and escalates unresolved quality issues to the Quality Leader. This seat does not run the controlled-substance vault and does not perform bench testing.]{contrast="auto"} [Key Responsibilities]{contrast="none"} - [Establish and maintain the FAS Quality Management System. This includes but is not limited to the Quality Manual and Quality Policy, master SOP index, document control, change control, deviations, CAPA, training records, and management-review inputs.]{contrast="auto"} - [Own the review and disposition of laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing. This is the Quality Unit disposition authority for FAS release.]{contrast="auto"} - [Own the investigation program. This includes but is not limited to OOS and OOT investigations, invalid assays, aborted runs, deviations, and documentation errors. Close investigations and decide disposition.]{contrast="auto"} - [Own CAPA. Confirm root cause, assign owners and due dates, verify effectiveness, and trend recurrence.]{contrast="auto"} - [Own document control. Issue, revise, obsolete, and archive SOPs, protocols, reports, forms, and controlled logbooks. Ensure only the current approved version is in use in the laboratory.]{contrast="auto"} - [Own change control for methods, equipment, software, facilities, materials, and procedures. Evaluate risk and impact and verify implementation before the change is used for reportable testing.]{contrast="auto"} - [Own the approval of method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before the method or instrument is used for GMP testing.]{contrast="auto"} - [Set the quality standard for sample management. This includes but is not limited to receipt, identification, chain of custody, storage, retention, and disposal, and review of controlled-substance inventories and destruction paperwork. This role does not own the vault.]{contrast="auto"} - [Own data integrity for paper and electronic records used by FAS, including Empower, Chromeleon, and LIMS (TEEXMA). Apply GDP, ALCOA+, and 21 CFR Part 11 requirements.]{contrast="auto"} - [Own the training and competency program. Maintain training records and confirm analysts are trained and authorized before they execute a method.]{contrast="auto"} - [Own supplier qualification and quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.]{contrast="auto"} - [Own internal audits and host regulatory inspections. Retrieve records, host auditors on quality-system topics, and own Quality Unit responses and commitments.]{contrast="auto"} - Establish and own quality metrics including deviations, OOS results, invalid assays, training gaps, overdue document reviews, CAPA aging, and audit findings. Escalate unresolved quality issues to the Quality Leader, FSS North America. ## Basic Qualifications [Bachelors degree in chemistry, biology, microbiology, or a related scientific field required. Advanced degree preferred.]{contrast="auto"}[]{ccp-props="{"} [Minimum 5 years of quality assurance experience in a cGMP pharmaceutical, 503B, or analyt ]{contrast="auto"}