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Position Title: Associate Diagnostic Technician - 1st Shift Packaging Work Location: Branchburg, NJ, 08876 Assignment Duration: 6 Months Work Schedule: Monday through Friday Work Arrangement: Fully Onsite
Position 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.
Qualification & Experience:
- Wearing Personal Protective Equipment (PPE)
- Lifting up to 25 lbs
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