QC Sample Coordinator II

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Date Issued: August 5, 2026 Application Deadline: August 12, 2025 Wage Level: hourly JOB DESCRIPTION: Position Title: QC Sample Coordinator II Location: Madison WI Department: Quality Control / Incoming materials and samples coordinator Reporting To: Manager, Quality Control Responsible For (Staff): No This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA ESSENTIAL DUTIES AND RESPONSIBILITIES: Review incoming material receipt packets to assess testing needs Regularly check USP, EP, and JP Compendia for material monograph updates Create and revise cGMP documents and Raw Material Specifications documents per current industry standards Schedule sampling of raw materials Routinely perform aseptic sampling inside a Biological Safety Cabinet Perform routine cleaning of sampling facilities Request quotes and purchase orders for testing performed externally Submit all applicable sample submission paperwork to the appropriate testing labs Assist with regular communications with 3rd party labs performing external testing Perform dimensional inspections on packaging components Manage shipment of all final product samples Review testing results to ensure accuracy and compliance Perform routine data generation and problem solving Escalate testing failure or safety concerns to management in a timely manner Independently manage deviation, out-of-specification or aberrant result investigations, as needed Assist with CAPA, MOC competition, and Audit responses, as needed Order/restock laboratory and office supplies, as needed. Complete assigned training in a timely fashion Attend scheduling meetings and communicate critical timelines or potential challenges to the pending manufacturing schedule Review final product and sampling plans for accuracy Coordinate training experiences for new hires on the sampling processes QUALIFICATIONS: Required: 2-5 years relevant business experience Proficient in MS Office. Must have strong attention to detail as well as ability to work in a cross-functional team environment Professional interpersonal skills and the ability to communicate well orally and in writing Ability to multi-task in a dynamic environment with changing priorities Ability to work independently as well as on a team, with limited supervisory oversight Master Control experience a plus cGMP experience a plus Special Demands: Must be able to walk and drive between local sites Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves Must be comfortable working with and handling hazardous materials in safety cabinets Must be able to safely lift 40+ lbs. #LI-RS1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.