- Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits.
- For participation in Filling Operations, job requirements will include ability to perform aseptic gowning and performing all filling tasks in the aseptic environment.
- As part of the production team, may perform in-process quality checks for specific quality attributes (Fill Check, Torque check, Vision System Check, Label Alignment Check ect.). Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements.
- Assists in completing all necessary production documentation (Production Manufacturing Records) and associated SAP transactions to ensure that all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation’s, etc.
- Cleans work area and decontaminates work surfaces in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.
- As required perform scheduled environmental monitoring activities in the Filling Suites.
- As required, performs warehousing activities according to defined procedures, which may include picking, issuing, returns, internal distribution of goods, receiving, shipping, etc.
High School Diploma
2 years previous experience in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience required
3 years previous experience in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience preferred
Experience in medical device or related industry preferred