Assoc Dia Tech - 2nd Shift Packaging

Position Title: Assoc Dia Tech - 2nd Shift Packaging

Work Location: Branchburg, NJ, 8876

Assignment Duration: 6 Months

Work Schedule: 2nd Shift (3:00pm to 11:30pm)

Work Arrangement: Onsite

Position Summary:

Responsible for labeling, inspecting and packaging of final container products with manual and/or automated packaging systems from distribution center to customer or clinical trial sites. May also set-up, change-over and operate labeling and packaging equipment.

Background & Context:

Production role supporting filling, labeling, and packaging operations in a regulated environment for The Organization.

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, reconciliation's, etc.

* Visually inspects products for defects and conformance to quality standards.

* 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 fill prep, picking, issuing, returns, internal distribution of goods, receiving, shipping, etc.

* Lifting requirements up to 50lbs.

* Other duties as assigned by management.

Qualification & Experience:

* High School Diploma or related.

* 0 - 2 years previous experience in an Operations/Production environment or filling, labeling or warehouse operations or equivalent combination of education and experience.

* Equivalent Combination of education and work experience.

Preferred:

* High School diploma and work- related experience.

* Previous experience in GMP Regulated environment.

Working Conditions & Physical Demands (If Applicable):

Lifting requirements up to 50lbs. Aseptic gowning required for filling operations. Environmental monitoring in Filling Suites.