Production Associate I - Human Tissue Manufacturing

Organogenesis•Norwood, MA

About The Position

The Production Associate I is an entry-level role responsible for production activities associated with Human Tissue Manufacturing (HTM) products. The associate follows applicable SOPs, MBRs, and cGMP procedures in the general laboratory area and Class 10,000 cleanroom, and works under supervision. The position reports to the Senior Manager, Human Tissue Manufacturing. The role includes processing HTM products, preparing media, reviewing batch records, maintaining equipment records and supply inventory, and documenting deviations and corrective/preventive actions as needed. Work must comply with quality systems requirements and company safety policies, including bloodborne pathogen handling procedures. The position requires extended periods in a cleanroom, manual dexterity, and the ability to safely lift up to 50 pounds. A pre-employment physical and lift test are required.

Requirements

A certificate in Biotechnology is preferred but not required.
One to three years of relevant experience is preferred.
Ability to operate general laboratory equipment and familiarity with general laboratory techniques, including balances, pipettes, stir bases, and heat sealers.
Ability to safely lift up to 50 pounds.
Manual dexterity.
Ability to work independently and as part of a team.
Ability to work in a cleanroom environment for extended periods.
Ability to remain stationary, often standing or sitting, for prolonged periods; communicate to exchange information; perform repeated motions involving the wrists, hands, and/or fingers; and assess the accuracy, neatness, and thoroughness of assigned work.
A pre-employment physical and lift test are required.

Nice To Haves

Certificate in Biotechnology.
One to three years of relevant experience.
Experience with aseptic technique and cleanroom protocols.

Responsibilities

Perform HTM production tasks, including layer separation, cleaning, spreading, cutting, milling, and packaging, under supervision and in accordance with quality systems regulations and established procedures.
Prepare media for production processes under supervision.
Review batch records for completeness, accuracy, and compliance with protocols.
Maintain equipment records.
Follow company safety policies, including procedures for handling bloodborne pathogens.
Maintain supply inventory as directed by the production schedule.
Write deviation and corrective/preventive action reports as necessary.

Benefits

401(k) with generous employer match, immediate vesting, and financial planning resources.
Medical, dental, and vision coverage options effective on the first day of employment.
Flexible Spending Account or Health Savings Account.
Company-paid short-term disability, long-term disability, and life insurance, with voluntary options also available.
Paid maternity leave and parental leave for all new parents.
Adoption benefits.
Education assistance of up to $5,000 per year for all employees.
Wellness program, including free mental health, mindfulness, and stress-reduction training, and on-site flu shots.
Employee Assistance Program.
Paid time off, including vacation, floating holidays, sick days, and company holidays.
Free parking, including an electric vehicle charging station at the Canton and La Jolla locations.
Discounts at BJ’s Wholesale, Dell, Sullivan Tire, and Sprint.