Responsibilities:

• 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.
• Accountable for on-time completion of assigned corporate, safety and on-the-job training.

Qualifications:

• High School Diploma or related field,
• or equivalent combination of education and work experience.
• Required: 2 years previous experience in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience
• preferably in a pharmaceutical or medical device industry.
• Preferred:  3 years of experience in an Operations/Production environment preferably in a pharmaceutical or medical device industry.