Production Associate I

Organogenesis • Canton, MA

9d • Onsite

About The Position

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength. Learn more about Careers at Organogenesis. The Production Associate will perform all activities involved in one of the following areas: the aseptic processing of a living product; the production of ICL and FortaFlex Products; or activities associated with HTP Product under the direct supervision the Manager. This role will support the Manufacturing Team by performing the tasks that will assure the safe and timely processing of our products, working in a Class 100/ISO 5, Class 10K/ ISO 7 and/or Class 100K/ISO 8 cleanroom.

Requirements

• High school diploma or equivalent required.
• Ability to work in a cleanroom environment, for extended periods of time.
• Dexterity, coordination, and some lifting are required.
• Ability to work independently as well as in a team environment.
• Must have the ability to lift to 50 pounds
• Remaining in a stationary position, often standing, or sitting for prolonged periods
• Repeating motions that may include the wrists, hands and/or fingers
• Medium work that includes moving objects up to 50 lbs
• Must have the ability to work safely and conscientiously in a manufacturing environment

Nice To Haves

• Bachelor’s degree or Biotech certificate, quality systems regulations (cGMP) knowledge and clean room experience preferred but not required.
• Aseptic Technique and cleanroom protocol experience desired
• Knowledge of standard lab techniques and equipment (eg. Balances, pipettes, stir bases, pH meters etc…)

Responsibilities

• Responsible for manufacturing our cellular based products according to established Master Batch Records and Operating Procedures under aseptic conditions.
• Perform all tasks associated with our HTP/collagen products such as layer separation, cleaning, spreading, cutting, milling, and packaging, for all HTP/collagen products with supervision in compliance with Quality Systems regulations and according to established procedure.
• Responsible for adherence to all Operating Procedures, Batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
• Review batch records for completeness and accuracy, as well as compliance with all protocols.
• Responsible for the writing of deviation and corrective/preventative action reports, as necessary.
• Responsible for the preparation of all media and sanitizing agents used in the Production areas.
• Rinsing, segregating equipment, inspecting for cleanliness, running glassware washers and responsible for preparing equipment.
• Measuring and cutting tubing, preparing Production set-ups per standard operating procedures, wrapping equipment in preparation for sterilization and responsible for sterilizing equipment
• Running depyrogenation ovens and autoclaves.
• Perform all tasks adhering to company safety policies, including but not limited to bloodborne pathogen handling.
• Maintain supply inventory as directed by the production schedule.
• Responsible for proper operation of all clean room equipment.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED