Quality Assurance Specialist Contractor

3 weeks ago


New Bedford, Massachusetts, United States BioSpace, Inc. Full time
Job Description

Job Title: Quality Assurance Specialist Contractor

Job Summary:

We are seeking a highly motivated and experienced Quality Assurance Specialist Contractor to join our team at BioSpace, Inc. The successful candidate will be responsible for planning, coordinating, and executing critical projects to support compliance with all regulatory requirements.

Key Responsibilities:

  • Provide QA support for the migration of controlled quality documents into our document repository.
  • Review existing quality, analytical, process, and manufacturing SOPs and associated documents and reports, and properly label them for future migration activities.
  • Create searchable metadata to easily find and retrieve documents for future use.
  • Collaborate with IT, QA, Analytical Development, Process Development, and other key partners.
  • Assist with the improvement of Quality Systems, including internal document review, change controls, deviations, investigations, and review of batch records.

Requirements:

  • Bachelor's degree in biology, chemistry, engineering, life sciences, or a related field, and 3+ years of relevant work experience (or M.S. and 1+ years of relevant work experience).
  • Experience with QA document control and management and Quality Systems.
  • Experience with management of controlled documents such as SOPs, manufacturing batch records, test records, deviations, CAPAs, and other quality records.
  • Experience with both paper and electronic QMS systems.
  • Strong command of SharePoint and labeling of quality documents.
  • Strong knowledge of GMP, SOPs, and quality system processes.
  • Ability to communicate effectively with scientific/technical colleagues and collaborate in a dynamic, cross-functional environment.
  • Ability to manage and deliver multiple projects in a fast-paced environment.

What We Offer:

  • A highly collaborative culture.
  • Competitive salary and benefits.
  • Potential for ownership through stock options.

How to Apply:

Please submit your application, including your resume and a cover letter, to [insert contact information].



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