Production Associate
Core
Facilitates label text approval, printing, and packaging activities for clinical supplies in a cGMP compliant environment.
Role type
Production Associate (Pharmaceutical Manufacturing)
Builds
Clinical supply kits and finished products
Domain
Biopharma / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
GMP compliance, label printing, batch record completion, facility cleaning, equipment maintenance, regulatory adherence (TGA/PIC/s), waste management, QA liaison
Preferred skills
cGMP facility license maintenance, audit assistance, process design input, third-party translator coordination, hardware evaluation
Technologies
GMP facilities, printing equipment, batch record systems
Responsibilities
Obtain label text approvals ensuring regulatory compliance, execute label printing per GMP and SOPs, complete packaging and labelling activities per batch records, perform line clearance and facility cleaning, verify equipment calibration and gowning requirements, reconcile printed and unprinted labels, assist in audits and deviation reporting
Seniority
Individual Contributor