QC Analyst I/II -Microbiology jobs in United States
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Organogenesis · 2 weeks ago

QC Analyst I/II -Microbiology

Organogenesis is a leading regenerative medicine company in the advanced and acute wound care space. They are seeking a QC Analyst I/II to perform routine quality control microbiology activities in support of product production and releases, ensuring compliance with regulatory requirements through testing and reporting results.

BiotechnologyHealth CareManufacturingMedical
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H1B Sponsor Likelynote

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

Microbiological testingEnvironmental MonitoringCGMP regulationsLaboratory safety proceduresData handling softwareCommunication skillsTeam collaboration

Required

AS or BS degree in a Microbiology or related field
1 or more years experience in a GMP or similarly regulated environment
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
Good communication skills both written and verbal
Physical Requirements: 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
Environmental Conditions: This position is primarily in a laboratory environment with approximately 20 % of the week in an office setting. The laboratory environment is a fast paced BL2 category lab that requires use of PPE such as gloves and lab coats. Activities are also performed in classified areas which require full gowning and special training. Standing for long periods of time and repetitive movements are associated with normal laboratory duties. The working environment includes working with chemicals such as disinfectants and will also involve exposure to human tissue products

Preferred

Knowledge of cGMP and GLP regulations and compendial requirement
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)
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

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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