Quality Assurance Specialist

3 days ago

Woburn, United States Masis Professional Group Full time

Quality Assurance Specialist


Our client is one of the world's largest providers of isotope technology for medical, scientific, and industrial use. The core businesses of the Group are Diagnostic Nuclear Medicine Imaging, Cancer Therapy, and Industrial Radiometry. Due to growth, they have an immediate opening for a Quality Assurance Specialist to join their dynamic & growing team


The company offers a very competitive compensation, bonus, 100% paid medical and dental, extremely generous 401k match, and other phenomenal benefits


The Quality Assurance Specialist reports to QA manager and helps to manage the QA system in a regulated radiopharmaceutical environment with regards to U.S. FDA cGMP and international regulations. This person assists in all activities to verify that appropriate, current procedures are followed, and keeps the leadership team fully informed, through verbal and written reports on the status of QA projects.


The Quality Assurance Specialist also manages documents, deviations, Out-of-Specification results, supplier qualifications, change control requests, customer complaints, customer and internal audits, regulatory authorities’ inspections, training of personnel and certifications for the site.


The Quality Assurance Specialist organizes and promotes company-wide quality improvement efforts as well as being responsible for administering the Corrective/Preventive Action (CAPA) program.


Quality Assurance Specialist Duties:

  • Develops the QA system under the guidance of the QA Manager.
  • Assures compliance with the company Quality Assurance systems.
  • Maintains files on current suppliers, training programs and the audit/inspection results.
  • Manages supplier qualification program.
  • Reviews and approves manufacturing and packaging batch records, as well as analytical results associated with commercial products as needed.
  • Represents the company during internal and external audits, and regulatory authorities’ inspections.
  • Develop the Document Management plan and update it, as needed.
  • Manage organizational documentation through the document life cycle.
  • Maintain organizational documents and the document management system.
  • Identify and investigate the need for documents of various types.
  • Ensure that organizational documents go through a documented and approved review-and-approval process before being stored.
  • Ensure that internal controls are in place and are functional.
  • Ensure the security, accessibility, and proper distribution of organizational documents.
  • Help develop and enforce documentation design, review, and storage guidelines


Quality Assurance Specialist Requirements:

  • Bachelor’s degree in a scientific or related field.
  • 2-3 years’ experience in Quality Assurance or in Documentation Management of Drug Products.
  • Excellent communication, verbal, and writing skills.
  • Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
  • Strong attention to detail
  • Ability to work independently and in a team environment.
  • Must have professional and cooperative attitude
  • Proficient in Microsoft Excel, Word, and Access
  • Able to lift to 50 lbs.

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