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Quality Assurance Specialist

Natick, MA
Expired: September 09, 2023 Applications are no longer accepted.
  • Full-Time
Quality Assurance Specialist, cGMP Cell Therapy, Orgenesis

Natick, MA

Orgenesis is a pioneering global biotech company that is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platform, with the ultimate aim of providing life-changing treatments at the Point of Care to large numbers of patients at low cost.

We are looking for a Quality Assurance Specialist to support the establishment and operation of the manufacturing facility, and lead Quality Assurance activities onsite. The Quality Assurance Specialist will be responsible for the implementing and maintaining of the quality system, and will take active part in the training, development and qualification of the on-site staff and facility. The ideal candidate will have experience in Quality Assurance related to cell therapy products manufactured in a cleanroom environment under cGMP.

Key Responsibilities include, but are not limited to:
  • Facilitate the maintenance of a quality management system in accordance with US FDA 21 CFR Parts 210, 211, and 600, 21 CFR Part 11, and other quality standards and regulations as needed
  • Administer the paper based QMS and the eQMS, to include validation and SOP generation
  • Lead and assist in quality audits and investigations within defined timelines (CAPA, Complaints, deviations, etc.)
  • Perform onsite recording of QMS data (collect/scan/email/post records)
  • Facilitate quality training and qualification of personnel and contractors
  • Assist in onsite office management (recording QMS minutes, setting up team teleconferences, purchasing)
  • Serve as the Doc Center - prepare and support all paperwork, including Batch Production Records associated with each production run
  • Remotly support other Orgenesis US sites as needed
  • Work with others to ensure timely and appropriate cross-functional alignment for each project

Key Requirements:
  • Minimum of a bachelor's degree in science or engineering
  • Broad understanding of cGMP (current Good Manufacturing Practices) and cGTP (current Good Tissue Practices).
  • In-depth experience working with the principles and techniques of data analysis
  • Ability to obtain comprehensive understanding of product specifications and functionality
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
  • Excellent written communication skills
  • Ability to think critically and takes collaborative approach to problem solving
  • Ability to work effectively in regulated and fast paced environment
  • High level of professional integrity and trustworthiness with strong work ethics

*Orgenesis does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) or supporting relocation for this employment position.



Natick, MA



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