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QC Analyst III/IV - Microbiology
Organogenesis Canton, MA
$92k-121k (estimate)
Full Time 1 Month Ago
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Organogenesis is Hiring a QC Analyst III/IV - Microbiology Near Canton, MA

Job Description:


About Us

We have unique opportunities 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 surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The QC Analyst III performs complex quality activities in support of product production and releases. The position has interaction with other internal departments including, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interaction with external entities including contractors and suppliers. The QC Analyst III performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. Holiday work required on rotating basis.

How You Will Achieve It:

  • Perform raw material, intermediate and non-routine testing
  • Perform endotoxin, microbiologic, and water testing
  • Perform reading environmental, personnel, and in-process sterility testing
  • Prepare and send out samples for microbiological identification and/or mycoplasma testing
  • Perform visual inspection of final product
  • Generate complex trend reports as they relate to quality testing
  • Revise SOPs
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
  • Participate extensively in high-level quality systems programs (CAPA, etc.).
  • Provide input into failure investigations
  • Participates, contributes, and adds value in cross- functional settings.
  • Collaborates and communicates appropriately in all situations.
  • Looks for ways to reduce errors and costs.
  • Takes ownership for meeting all deliverables.
  • Responsible for initiating, investigating, and closing environmental monitoring excursion reports
  • Supporting preparation and adjustments to weekly schedule
  • Fast-paced high energy team-oriented work environment
Job Requirements:


What You Need to Achieve It:

  • Requires a Bachelor’s Degree in Microbiology or related field, with a minimum of 5-7 years of Microbiology experience in a GMP/Medical Device/ Pharmaceutical or Biological regulated environment.
  • Experience in Aseptic Processing is preferred.

Physical Requirements:

  • This position may require a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K.
  • This position may require 2-3 hours of standing per day with frequent stooping and lifting

What sets us apart?

  • Competitive Pay
  • 401K – vested immediately with 100% match
  • Education Assistance Policy - $5,000 per year for all employees
  • Medical, Dental and Vision
  • Flexible Spending Account or Health Savings Account
  • Wellness Program
  • Three weeks of vacation, 4 floating holidays, sick days, and company holidays
  • Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, or any other characteristic protected by law.

Job Summary

JOB TYPE

Full Time

SALARY

$92k-121k (estimate)

POST DATE

03/24/2024

EXPIRATION DATE

05/23/2024

WEBSITE

organogenesis.com

HEADQUARTERS

CANTON, MA

SIZE

500 - 1,000

FOUNDED

1985

TYPE

Public

CEO

GARY S GILLHEENEY SR

REVENUE

$200M - $500M

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About Organogenesis

Organogenesis is a Massachusetts-based regenerative medicine company that develops bioactive and acellular biomaterials products to treat orthopedics and spine diseases.

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