QC Sample Coordinator I

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.

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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Review all incoming material receipt packets to assess testing needs
• Schedule and perform sampling of raw materials across the PCI Madison, WI Sites
• Request quotes and purchase orders for testing performed externally
• Assist with regular communications with 3rd party labs performing external testing
• Complete and submit all applicable sample submission paperwork to the appropriate testing labs
• Escalate testing failure or safety concerns to management in a timely fashion
• Assist in deviation, out-of-specification or aberrant result investigations, as needed
• Assist with the writing and revision of cGMP documents and Raw Material Specifications documents to meet industry standards
• Assist with reviewing testing results to ensure accuracy and compliance.
• Perform routine cleaning of sampling facilities
• Routinely perform aseptic sampling inside a Biological Safety Cabinet
• Perform dimensional inspections on packaging components
• Perform routine data generation and problem solving
• Order/restock laboratory and office supplies, as needed.
• Complete assigned training in a timely fashion

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• 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

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Laboratory, manufacturing, warehouse

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 0-3 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 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

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.