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.
- Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards.
- Follows all department work instructions, SOPs, OSHA safety regulations.
- Executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines.
- As part of the production team will perform in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects.
- Must have the ability to wear protective gowning as manufacturing steps are performed in an environmentally controlled area.
- Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc.
- Completes necessary manufacturing records legibly and accurately.
- Executes SAP and electronic batch record transactions to ensure 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.
- Monitors laboratory supply inventory, replenishes lab supplies as needed. Performs general/routine laboratory maintenance/upkeep.
- Communicates and interfaces directly with internal groups to ensure that laboratory equipment maintenance and calibration are completed as scheduled.
- Performs material handling activities according to defined procedures, which includes picking, issuing, stock transfer and receipt transactions.
- High School Diploma or related field, or equivalent combination of education and work experience.
Job Related Experience:
- Required: 2 years in an Operations/Production environment preferably in a pharmaceutical or medical device industry.
- Preferred: 3 years in an Operations/Production environment preferably in a pharmaceutical or medical device industry.