Production Associate III-Solutions Prep jobs in United States
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Organogenesis · 6 hours ago

Production Associate III-Solutions Prep

Organogenesis is a company focused on advanced wound care and regenerative medicine products. The Production Associate III is responsible for preparing sterile and non-sterile solutions, assisting with training team members, and ensuring compliance with established procedures in an ISO 7 clean room environment.

BiotechnologyHealth CareManufacturingMedical
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H1B Sponsor Likelynote

Responsibilities

Responsible for preparing all solutions according to established Master Batch Records and Operating Procedures
Measuring chemicals
Mixing
PH/osmolality assessment
Aseptic Dispensing
Line Clearance
Responsible for assuring all batch records are complete and are compliant with all protocols
Assisting in coordinating training of new personnel
Assist with technical training and updating Solution Prep associates
Assist with scheduling, performing (when applicable), and documenting training of Solution Prep associates
Assist with maintaining personnel training records
Assis with aseptic requalification and assisting in performing annual re-certification (if applicable) of team members
Participate in the execution of the Aseptic Process Simulation Re-Validation on a semi-annual basis
Assist in Maintaining the ISO 7 laboratory area
Ensuring cleaning of Equipment
Maintenance of Monthly Equipment Logs
Maintain FIFO of Glassware, Chemicals, and Autoclaved materials
Adherence to all Operating Procedures, Protocols, Policies, Regulatory Requirements, GMP, and Safety Guidelines
Participate in ordering Supplies for Solution Prep Area
Participate in Hazardous Waste disposal
Participate in Writing and Revising manufacturing documents and procedures and ensuring compliance with biennial review requirements
Assist with maintaining all records and adherence to established guidelines for Quality Control procedures, cGMP, and Safety
Assist in deviation investigations and CAPAs, as needed

Qualification

Aseptic skillsGMP manufacturingSolution PreparationBiological Science degreeQuality Systems regulationsElectronic Documentation systemManual dexterityBasic computer skillsProblem solving skillsCommunication skillsWriting skillsOrganizational skillsTaking initiativeLeadership ability

Required

B.S. or A.S. in Biological Science or equivalent, with 3-5 years of relevant experience
Aseptic skills are highly desirable
Experience in Solution Preparation or GMP manufacturing (3+ years experience) is desirable
Proficiency with computers preferred (MS Excel, MS Word, ERP system)
Quality Systems regulations (cGMP) knowledge and clean room experience desired
Ability to work in a clean room environment
Work as a member of a team as well as independently
Problem solving skills
Manual dexterity
Heightened awareness and attention to detail
Ability to lift and move objects in excess of 25 lb
Consistently demonstrates proficiency in the application and use of new and existing technologies
Assist in training of scientific and technical principles, techniques and procedures
Communication skills
Writing skills
Basic computer skills with a working knowledge of Microsoft Word and Excel
Proven organizational and documentation skills
Knowledge of an Electronic Documentation system, example: Smart Solve
Taking initiative
Proven leadership ability

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

Company

Organogenesis

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Organogenesis Inc. is a regenerative medicine company.

H1B Sponsorship

Organogenesis has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (1)
2022 (7)
2021 (1)

Funding

Current Stage
Public Company
Total Funding
$614.7M
Key Investors
Silicon Valley BankEastward Capital Partners
2024-11-27Post Ipo Equity· $130M
2021-08-09Debt Financing· $200M
2020-12-02Post Ipo Equity· $64.7M

Leadership Team

M
Michael Catarina
Chief Technology Officer
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David Francisco
Chief Financial Officer
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Company data provided by crunchbase