Organogenesis · 4 months ago
QC Analyst II/III-Histology
Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary)
Full-time
Hybrid
Mid Level
3+ years expOrganogenesis is a company that specializes in advanced wound care products and regenerative medicine solutions. They are seeking a QC Analyst II/III to perform advanced quality activities in support of product production and releases, ensuring compliance with regulatory requirements through testing and reporting results.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Primary responsibility for the day-to-day activities in the Histology laboratory in support of material and product release testing
Morphological evaluation for release of final product and/or process development samples
Scientific/technical contributor on cross-functional projects related to Histology activities and assay development/optimization
Interact and coordinate with Manufacturing and QA Operations daily
Tracking sample receipt
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
Assist with inter-departmental interactions to ensure customer service needs are satisfied and priorities understood
Identifies and implements issues and opportunities for improvements
Revise/Create SOPs
Qualification
Required
Bachelor's Degree in a Life Science
3-4 years of experience in a GMP/GLP regulated environment
ASCP Certified
Advanced working knowledge of statistics
Proficient in the use and application of quality tools, databases, and process skills
Advanced knowledge of relevant Quality System and SOP procedures
Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO
Ability to interpret and apply quality and regulatory standards
Advanced working knowledge of tooling, test equipment, laboratory techniques, and CGMP
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
Organogenesis Inc. is a regenerative medicine company.
501-1000 employees
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 CompanyTotal Funding
$614.7MKey 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
David Francisco
Chief Financial Officer
Recent News
MarketScreener
2025-12-24
2025-12-24
Company data provided by crunchbase