Shift: M-F, 11:00 pm-7:30 am
This position is eligible for a shift differential.
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
- Leads sub teams of assigned operators to perform filling/packaging/ labeling/label printing and/or visual inspections to complete assigned production operations. The Individual can set-up, troubleshoot, and participate in changeovers of Fill/Package/Label equipment as required.
- Candidate is the subject matter expert in the set-up and operation of automatic and semi-automatic filling, labeling, and Packaging/warehouse equipment to provide coverage as required to meet production plans.
- Candidate ensures that during every production operation, that all in-process tests required to be performed by the team (Fill, torque, label alignment) are taken as required and meet predetermined acceptance criteria. Individual will operate specialized laboratory, packaging, and warehouse equipment as necessary. Monitors storage units (refrigerators/freezers) as required.
- Candidate will lead or assist in the training of Diagnostic Tech and Diagnostic Inspectors for Filling, Packaging operations to perform all production tasks to meet replenishment demands.
- Inspects products for defects and conformance to quality standards and applicable SOPs. Participates in performing all required in-process product checks and visual inspections as required. Participates in filling of hazardous materials and ensures all production tasks performed by the sub-team are performed safely and according to written procedures.
- Ensures all documentation generated during scheduled manufacturing operations (batch production records, packaging records, in-process test data) is completed correctly and accurately by the sub-team. Performs SAP system transactions as required to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation, etc. In SAP, performs transactions to issue components to order, receive stock into inventory and issue samples as required. Understands GMP, QSR, ISO and RMS Quality regulations and ensures operations are performed according to those requirements.
- Prior to the initiation of production activities, ensures work area is cleaned and work surfaces decontaminated in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements. Prior to initiation of production activities, ensures that scheduled environmental monitoring activities has been performed as required in the Filling Suites.
- For participation in Filling Operations, job requirements include ability to perform aseptic gowning and performing all filling tasks in the aseptic environment
- Other duties as assigned by management.
- Be a back-up lead when required.
- Acts as an ambassador in championing world class quality and safety in the factory.
- High School Diploma or equivalent required
- Associate's Degree preferred
THIS POSITION IS NOT ELIGIBLE FOR RELOCATION BENEFITSWho we are
- 4 years in filling, labeling or warehouse operations, preferably in a pharmaceutical or medical device industry required (5 years preferred)
- Equivalent combination of education and work experience accepted
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.