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Production Associate Dermagraft

Organogenesis

📍 Smithfield, Rhode Island

Posted 1 months ago

Quick Info

Salary Range

$24 - $24

Job Type

Full Time

Specialty Skills

cGMPAseptic TechniqueCleanroom ProtocolsBiotechnology

About the Role

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 How You Will Achieve It: * 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’s, and safety. What You Need to Achieve It : * Associates or Bachelor’s degree in biology or related science and/or 0 - 2 years experience. Experience in aseptic technique, cGMP and clean room protocols desired. * Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience. * Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required. * Aseptic Technique and cleanroom protocol experience * Basic knowledge of laboratory techniques * Must be able to work as a team member and independently as required. * Ability to perform calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures. * Aseptic technique, clean room gowning and extensive knowledge of Good Manufacturing Practices (GMPs), with an emphasis on cellular based Products. * Effectively communicate with internal and external group members by collaborating with sub-teams within manufacturing and across Organogenesis. * 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. Physical 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, What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint