Job Information
OSRX, Inc. Quality Control Sample Management Supervisor in Missoula, Montana
Position SummaryQualifications- Strong attention to detail with a focus on accuracy and compliance.- Excellent documentation and organizational skills.- Effective communication and cross-functional collaboration abilities.- Proficiency in computer systems and data management tools.- Experience in a cGMP-regulated environment preferred.- Demonstrates reliability and consistent attendance.Job Duties and Responsibilities- Sample Management & Tracking- Oversee the receipt, unpacking, identification, and accessioning of samples.- Ensure proper handling, labeling, storage, and chain of custody for all samples.- Prepare samples for shipment to third-party laboratories (3PL) and coordinate external testing.- Generate and track test requests for internal and external laboratory analysis.- Monitor testing status for raw materials, in-process samples, bright stock, and stability studies.- Provide notification of delays, communicating with cross-functional stakeholders as needed.- Documentation & Data Integrity- Ensure accurate, timely data entry and maintenance of sample records.- Review, organize, transcribe, and archive laboratory documentation.- Generate Certificates of Analysis (CoAs) for product release and distribution.- Compile and route completed test results for appropriate review and approval.- Laboratory Coordination- Act as the primary liaison between QC and external laboratory partners.- Coordinate in-house testing requests and maintain visibility of testing progress by batch/lot.- Maintain strong vendor relationships and aid to resolve testing or sample discrepancies.- Sample Storage & Retention- Oversee proper storage and maintenance of retain samples.- Follow sample retention programs, including compliant disposal processes.- Systems & Compliance- Utilize inventory management systems (e.g., LifeFile) to ensure accurate sample tracking.- Ensure adherence to cGMP requirements, internal procedures, and regulatory standards.- Operational Support- Support stability study documentation and tracking.- Review and approve testing invoices, cross referencing completed testing.- Submit purchase orders, when needed, for projects and non-routine testing.- Request quotes and support planning for testing-related projects.- Participate in cross-functional meetings on behalf of Quality Control.Must pass a background check prior to hire. Benefits include health, dental, vision, life, disability, 401K, holidays, and paid time off after qualified employment term.