Production Associate Dermagraft

Role Summary

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Dermagraft), under the direct supervision of the Dermagraft Team Leader/Dermagraft Supervisor/Manager. The Dermagraft Associate will support the Dermagraft Manufacturing department by performing the tasks that will assure the safe and timely processing of Dermagraft, working in both a ISO 7 and ISO 8 cleanrooms. The hours for this position are Monday-Friday-7:30 am -4:00 pm.

Responsibilities

• Responsible for aseptically manufacturing Dermagraft according to established Master Batch Records and Operating Procedures associated with cell-growth functions, including seeding cells, media changes, and harvesting of final product and packaging for commercial distribution.
• Responsible for the preparation of all media and sanitizing agents used in the Production areas as well as prepping materials for autoclaving and autoclaving the materials.
• Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, cGMP, and safety guidelines.
• Responsible for assuring batch records are complete and are compliant with all protocols.
• Responsible for proper operation of all clean room equipment.
• Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, cGMP‚Äôs, and safety.

Qualifications

• Required: Associates or Bachelor‚Äôs degree in biology or related science and/or 0 - 2 years experience. Experience in aseptic technique, cGMP and clean room protocols desired.
• Required: Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience.
• Required: Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required.
• Required: Aseptic Technique and cleanroom protocol experience
• Required: Basic knowledge of laboratory techniques
• Required: Must be able to work as a team member and independently as required.
• Required: Ability to perform calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures.
• Required: Aseptic technique, clean room gowning and extensive knowledge of Good Manufacturing Practices (GMPs), with an emphasis on cellular based Products.
• Required: Effectively communicate with internal and external group members by collaborating with sub-teams within manufacturing and across Organogenesis.
• Required: Due to the nature of production work, overtime and weekend work as well as Holiday work is a requirement of employment and is variable based on company needs.

Education

• Associates or Bachelor‚Äôs degree in biology or related science.

Additional Requirements

• Ability to work in a cleanroom environment, fully gowned, for extended periods of time
• Dexterity, coordination and must be able to push 150+ lbs. (on wheels), and lift 50lbs.
• Must work with living human cells and various chemicals.
• Pre-employment physical and lift test required