Location
Santa Clara, CA | United States
Job description
Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
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 ect.). 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.
Qualifications
Required: 2 years previous experience in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience. Highschool diploma preferred.
Job tags
Salary
