Organogenesis · 2 months ago
QC Analyst I/II -Microbiology
Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary)
Full-time
Onsite
Entry, Mid Level
$54K/yr - $84K/yr
1+ years expOrganogenesis is a leading regenerative medicine company in the advanced and acute wound care space, committed to empowering healing. The QC Analyst I/II will perform routine quality control microbiology activities to support product production and releases, ensuring compliance with regulatory requirements through various testing and reporting activities.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Perform and read environmental monitoring, critical utilities and personnel testing samples
Perform and support microbiological testing, such as plate count enumeration, critical utilities monitoring, endotoxin testing, environmental monitoring, bioburden, and growth promotion
Perform raw material, intermediate and non-routine testing
Perform general laboratory maintenance activities
Prepare and send out samples for microbiological identification and/or mycoplasma testing
Assist in revising SOPs
Perform
Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
Participate in high-level quality systems programs (Excursions, deviations CAPA, etc.)
Participates, contributes and adds value in cross- functional settings. Collaborates and communicates appropriately in all situations
Independently plans to execute projects and knows when to include others. Looks for ways to reduce errors and costs
Takes ownership for meeting all deliverables
Qualification
Required
This position requires a minimum of 25 hours/week gowned in classified areas; ISO 5, ISO 7, ISO 8, and CNC
Handling biohazardous materials and chemicals
Basic laboratory safety procedures
Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filling out reports. (Microsoft Excel, Word, Outlook and Access)
Good communication skills both written and verbal
This position requires 3-5 hours of standing per day with frequent stooping and lifting
This position also requires use of repetitive hand movement e.g. micropipetting and keyboard use for moderate or long periods of time
Occasional lifting/moving up to 15 pounds
Pre-Employment Testing: Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment
The working environment includes working with chemicals such as disinfectants and will also involve exposure to human tissue products
Perform routine quality control microbiology activities in support of product production and releases
The position interacts with other internal departments, including Apligraf Production, PuraPly Production, Quality Assurance, Validation, Calibration, Materials, and Logistics
The position may interact with external entities including contractors and suppliers
The QC Analyst I/II performs a wide variety of routine activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting result
The schedule for this role is a Monday-Friday 11:00 am-7:00 pm, some holiday work is required
Training schedule for this role is Monday-Friday 8:30 am-5:00 pm (first 3-6 months)
Perform and read environmental monitoring, critical utilities and personnel testing samples
Perform and support microbiological testing, such as plate count enumeration, critical utilities monitoring, endotoxin testing, environmental monitoring, bioburden, and growth promotion
Perform raw material, intermediate and non-routine testing
Perform general laboratory maintenance activities
Prepare and send out samples for microbiological identification and/or mycoplasma testing
Assist in revising SOPs
Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
Participate in high-level quality systems programs (Excursions, deviations CAPA, etc.)
Participates, contributes and adds value in cross-functional settings
Collaborates and communicates appropriately in all situations
Independently plans to execute projects and knows when to include others
Looks for ways to reduce errors and costs
Takes ownership for meeting all deliverables
Preferred
AS or BS degree in a Microbiology or related field
1 or more years experience in a GMP or similarly regulated environment
Knowledge of cGMP and GLP regulations and compendial requirement
Experience with in testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, and Growth Promotion testing
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
2026-01-09
MarketScreener
2025-12-24
Company data provided by crunchbase