QC Sample Coordinator I

PCI Pharma Services•Madison, WI

About The Position

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.

Requirements

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
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

Nice To Haves

Master Control experience a plus
cGMP experience a plus

Responsibilities

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 3 rd 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