QC Analyst III-Cell Culture (Sunday-Thursday) jobs in United States
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Organogenesis · 4 hours ago

QC Analyst III-Cell Culture (Sunday-Thursday)

Organogenesis is a company dedicated to empowering healing through advanced wound care products and regenerative medicine solutions. The QC Analyst III will perform advanced quality activities to support product production and releases, ensuring compliance with regulatory requirements, while interacting with various internal departments and external entities.

BiotechnologyHealth CareManufacturingMedical
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H1B Sponsor Likelynote

Responsibilities

Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing
Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and assay development/optimization
Interact and coordinate with Manufacturing and QA Operations daily
Coordination of test sample receipt and scheduling
Execute assigned tasks with minimal supervision
Donated tissue receipt and transfer
Identify and report areas for process improvement
Generate and execute feasibility/validation protocols
Generate trend reports as they relate to quality testing
Work closely with team members to ensure timely release of materials
Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations
Revise/Create SOPs

Qualification

Cell Culture experienceGMP regulated environmentFlow CytometryBiology degreeProcess improvementSOP revisionTeam collaboration

Required

Bachelor's degree in Biology or related field, with 5-7 years of related experience
Cell Culture experience required
Experience in GMP regulated environment preferred
Flow Cytometry [FACS CANTO II] experience preferred
Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing
Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and assay development/optimization
Interact and coordinate with Manufacturing and QA Operations daily
Coordination of test sample receipt and scheduling
Execute assigned tasks with minimal supervision
Donated tissue receipt and transfer
Identify and report areas for process improvement
Generate and execute feasibility/validation protocols
Generate trend reports as they relate to quality testing
Work closely with team members to ensure timely release of materials
Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations
Revise/Create SOPs
This position requires repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time
Occasional Class 10K gowning is required to support QC activities

Preferred

Experience in GMP regulated environment preferred
Flow Cytometry [FACS CANTO II] experience preferred

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