As a Materials Specialist, you are responsible for the execution of product logistics in a cGMP environment. This includes the receipt and inspection, storage, wipe down, and issuance of kitted and non-kitted GMP materials used in production and final product shipping/distribution to our customers. This includes performing data entry into various business systems and databases to ensure department compliance with policies and procedures.
Additional responsibilities include:
Ensuring safe and compliant handling, storage, and dispensing of GMP materials, including coordination of expired materials and participation in internal GMP inspections
Collaborating with various departments to coordinate shipping and receiving, as well as maintaining general supplies and restocking GMP areas
Creating and revising standard operating procedures (SOPs) relevant to department processes
Performing department-related project activities, including investigating, analyzing, formulating possible solutions, documenting processes, and communicating results
Scheduling transportation for outgoing shipments for inbound and outbound operations
Using manual labor, pallet jacks, and forklifts to move product and both GMP and non-GMP supplies to and from storage locations and delivery trucks
You must have the ability to, on occasion, work overtime, holidays, weekends, and various shifts as required to meet business and customer needs.
Who You Are: You possess a High School Diploma or equivalency AND 4+ years of relevant experience
You are a clear communicator with a strong organizational and interpersonal skills
You have proven experience in analytically investigating and troubleshooting system issues, driving the implementation of solutions, planning, prioritizing, and completing work with minimal supervision, and working with Quality management systems on deviations, change control, and corrective/preventive actions
You are proficient in basic mathematical skills for accurate calculations
You possess technical proficiency with various computer applications and business operations software (i.e. gSuite, MS Office, ERP systems such as SAP)
You have proven experience to effectively lead, coach, and influence within a collaborative and fast-paced work environment
You are capable of regularly moving/lifting objects weighing up to 50 lbs with or without an accommodation.
Preferred Experience:
Lean methodology
Cell therapy manufacturing
Experience working in a personalized health care environment.