QA Lab Associate

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13702331 ## 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 Associate will support the quality compliance profile by acting as the primary on-site person responsible for quality systems, data review, and disposition of laboratory testing at Fagron Analytical Services.]{contrast="none"} [Additionally, the Quality Assurance Associate will serve as liaison to Chemistry, Microbiology, and other functional areas within the FAS organization to support an overall culture of awareness and cGMP compliance. This position is independent of laboratory operations and has the authority to approve or reject procedures, methods, results, investigations, and dispositions.]{contrast="none"} [Key Responsibilities]{contrast="none"} - [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="none"} - [Review and approve or reject laboratory results, worksheets, chromatograms, and certificates of analysis for Chemistry and Microbiology testing.]{contrast="none"} - [Lead laboratory investigations. 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="none"} - [Initiate, own, and track CAPA. Confirm root cause, assign owners and due dates, verify effectiveness, and trend recurrence.]{contrast="none"} - [Control documents and records. 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="none"} - [Administer 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="none"} - [Review and approve method validation, verification, transfer, and equipment qualification (IQ/OQ/PQ) packages before the method or instrument is used for GMP testing.]{contrast="none"} - [Oversee sample management quality. 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.]{contrast="none"} - [Ensure 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="none"} - [Administer the training and competency program. Maintain training records and confirm analysts are trained and authorized before they execute a method.]{contrast="none"} - [Support supplier qualification and quality agreements for critical laboratory suppliers, reference standards, and contract laboratories.]{contrast="none"} - [Support internal audits and regulatory inspections. Retrieve records, host auditors on quality-system topics, and own Quality Unit responses nd commitments.]{contrast="none"} - [Trend 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.]{contrast="none"} - [Follow standard operating procedures to ensure compliant handling of laboratory records, hormone products, and controlled-substance testing documentation.]{contrast="none"} ## Basic Qualifications [Bachelors degree in chemistry, biology, microbiology, or a related scientific field required. Equivalent cGMP quality experience may be considered.]{contrast="none"}[]{ccp-props="{"} [Minimum 2 years of quality assurance or quality-control ]{contrast="none"}