QC Analyst I/II -Microbiology (Sunday-Thursday)

Organogenesis, Inc.•Canton, MA

65d•Onsite

About The Position

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: 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

Requirements

AS or BS degree in a Microbiology or related field preferred 1 or more years experience in a GMP or similarly regulated environment preferred
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
Knowledge of cGMP and GLP regulations and compendial requirement, preferred
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

Nice To Haves

Experience with in testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, and Growth Promotion testing preferred

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.

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)
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