Associate Diagnostic Technician

Job Summary
Responsible for labeling, inspecting and packaging of final container products with manual and/or automated packaging systems. May also set-up, change-over and operate labeling and packaging equipment. Responsible for data entry and imprinting computer generated labels. Maintains records and manufacturing/production area to comply with regulatory requirements, good manufacturing practices and standard operating procedures. May perform initial check of completed documents for completeness and accuracy.

Key Responsibilities
- 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, etc.). 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, reconciliations, 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.
- Other duties as assigned by management.

Physical Requirements & PPE
- Wearing Personal Protective Equipment (PPE)
- Lifting up to 25 lbs