Associate Production Tech (Diag Tech), Filling - 2nd Shift

Associate Production Tech (Diag Tech), Filling - 2nd Shift

Onsite in Branchburg, NJ. PayXXXXXXXXXXX.

Job Profile

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. 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.

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.

Required:

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.

Preferred:
High School diploma and work-related experience. Previous experience in GMP Regulated environment.