QA Specialist II

Canton, MA

Job Req code: 735

Category: Quality Systems

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. Empowering Healing.

Organogenesis corporate headquarters is in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds).  Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products. 
 

The QA Specialist is a multifunction position supporting QA Operations, QA Training and QS Documentation.  The position has a great deal of interaction with many internal departments, including Production, Facilities, Quality Control, and Materials Management.  The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements and internal procedures.

Review internal document for accuracy and compliance with GMP’s
Perform tasks within the Electronic Quality Management System, including:
Data entry/Data cleanup
Running training compliance reports and performing follow-up
Ensures the issuance of production batch records (MBR's), Nonconforming Material Reports (NCMR's), Deviations, GMP Investigations, MS item numbers, Part Numbers, and Out-of-specification Numbers.
Maintain databases for Document Control inventory.
Maintain archival of all GMP records per established process.
Perform additional QA functions as required
Communicate any areas of deficiency to the responsible individuals
To perform this job successfully, an individual must be able to perform each essential function satisfactorily and have strong knowledge and experience in Microsoft Office as well as experience in FDA regulated environment. The requirements listed below are representative of the knowledge, skills and/or abilities required.

Proficiency in Microsoft Office including Microsoft Word and Excel
Excellent written and verbal communication skills, including technical writing skills
Exceptional organizational, attention to detail and document management skills
Experience in a pharmaceutical or biotech manufacturing environment preferred

Requirements

A Bachelor’s degree or equivalent with demonstrated knowledge of scientific principles in a GMP regulated environment is desirable. 2-5 years of GMP experience in a Medical Device/Biotechnology industry.