Production Associate I - Apligraf

Canton, MA

Job ID: 498

Job Req code: 498

Category: Production

Job Type: Production

The Production Associate I performs all activities involved in the aseptic processing of a living product (Apligraf).  This individual supports the Manufacturing Department by performing tasks that will assure the safe and timely processing of Apligraf.  This position requires working in a regulated area under the direct supervision of a team leader or departmental supervisor.  This is an entry level position. The regular hours for this position are Monday-Friday, 7:30 am - 4:00 pm, with flexibility for earlier hours. Initial training will occur during early morning hours (approximately 5:00 am -6:00 am) for a period of several weeks.

Responsibilities Include:
Manufacture of Apligraf according to established master batch records and operating procedures
Assure batch records are concurrently documented, reviewed, and are cGMP compliant
Preparation of media and disinfectants used in the Production areas
Responsible for adherence to all operating procedures, policies, protocols, regulatory requirements and cGMP regulations
Performs all tasks in compliance with company safety policies especially involving chemical safety and proper lifting techniques 
Responsible for proper operation of all clean room equipment
Provides assistance with process optimization and scale-up activities, if necessary
May provide assistance to Engineering and Facilities Departments, as necessary, for equipment operation during calibration, validation, or repair
Maintains laboratory inventory supply, ensuring accurate inventory accounting
May write deviation reports
Performs related duties as directed

Requirements

A High School diploma or equivalent is required
A certificate in Biotechnology, Associate's degree, Bachelor's degree in Biology or a related science discipline is preferred 
Prior experience in general lab techniques, aseptic technique, GMP and clean room protocols is desired
Ability to work in a cleanroom environment, for extend periods of time
Dexterity, coordination, and some lifting is required