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

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