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Quality specialist ii
Organogenesis Canton, MA
$81k-100k (estimate)
Full Time 1 Month Ago
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Organogenesis is Hiring a Quality specialist ii Near Canton, MA

Quality Documentation Specialist II

150 Dan Road, Canton, Massachusetts, 02021, United States

Job Req code 369

Category : Quality

About Us

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.

About Us

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 :

The QS Documentation Specialist II supports the documentation activities in support of product production and release. The position has a great deal of interaction with many other departments, including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory and Logistics.

The primary responsibilities are SmartSolve Document Management routing and approval, ensuring security and easy retrieval of the controlled files, batch record issue and supporting production needs.

  • Perform SmartSolve Document Management routing, review, and approval activities. Issue training Packets, as needed.
  • Issue batch records (MBR's) to Production weekly, as well as OOS’s to the appropriate individuals as needed
  • Maintain databases for Document Control room inventory
  • Control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams
  • Responsible for filing and maintaining archived documents.
  • Responsible for assisting with the destruction of documents that are outside of the required retention period and / or assisting with the preparation of records for storage offsite
  • Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods
  • Review Facilities documentation for compliance prior to filing in the Equipment History Files.
  • Communicate any areas of deficiency to the responsible individuals
  • Maintaining the cell bank database in Excel by entering new binders into inventory and tracking the hard copies taken for reference.
  • Scan and make copies as necessary

Requirements

What You Need to Achieve It :

  • Requires Bachelor’s Degree or equivalent
  • 2 - 5 years of related experience in a GMP / GLP regulated environment
  • Documentation experience required

What can we offer you?

  • 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

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, genetic information or any other characteristic protected by law.

Last updated : 2024-05-04

Job Summary

JOB TYPE

Full Time

SALARY

$81k-100k (estimate)

POST DATE

05/05/2024

EXPIRATION DATE

06/21/2024

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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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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