Shift: M-W 6:00pm-7:00am

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:

• Oversee work groups which conduct filling operations and is responsible for the accuracy, quality and timeliness of filling operations.
• Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards.
• Follows all department work instructions, SOPs, OSHA safety regulations.
• Understands GMP, QSR, ISO and RMS Quality regulations and ensure that all production operations are performed in a manner that meets these requirements.  
• 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.
• Completes necessary manufacturing records legibly and accurately.  
• Completes necessary filling documentation (production manufacturing records) and associated 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. 
• Communicates and interfaces directly with internal groups to ensure that laboratory equipment maintenance and calibration are completed as scheduled.
• Uses basic laboratory equipment to complete manufacturing and filling activities including scales, etc.
• Individual is skilled in the operation of all automatic and semi-automatic filling and pouching equipment.
• Individual will assist in training of staff on processes and procedures.
• Keeps Area Manager informed of product and production schedule status, particularly of significant observations and potential production delays. 

QUALIFICATIONS:

Education:

• Required:  High School Diploma, or equivalent combination of education and work experience. 
• Preferred:  Associate Degree
   

Job Related Experience:  

• Required: 5 year experience in supervising filling, packaging, operations, preferably in a pharmaceutical or medical device industry.
• Preferred:  7 year previous experience in supervising filling, labeling or warehouse operations in a pharmaceutical or medical device industry.