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Quality Assurance Associate

Boston Competitive p/h Contract

Responsibilities:

  1. Promote Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and overall compliance actively.
  2. Provide assistance in releasing incoming raw materials.
  3. Collaborate with Supply Chain and Manufacturing teams to facilitate the dispensing of raw materials for batch production.
  4. Assist QC, Analytical Research and Development (ARD) in reviewing, approving, and filing Certificates of Analysis (CoA).
  5. Oversee quality aspects of clinical phase manufacturing, ensuring GMP compliance. This includes issuing production batch records, conducting line clearance, maintaining a QA presence on the floor, and performing checks on raw materials, components, and in-process materials.
  6. Support the review of batch documentation, deviations/investigations, change control, and issue resolution for Intermediate and Drug Product (DP) Disposition.
  7. Participate in document life-cycle and training management, including initiation, document numbering, revision, approvals, distributions, and the review and filing of training documentation.
  8. Review documents for formatting, template usage, completeness, and consistency.
  9. Assist in creating and maintaining templates for various document types.
  10. Provide support in maintaining employee training records and contribute to the development of department curricula.
  11. Actively participate in the continuous improvement of quality systems.

Essential Requirements:

  • Minimum of a BA/BS in a science-related field.
  • 2-5 years of relevant work experience in the pharmaceutical, biotech, or medical device industry.
  • Knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices, and their application in pharmaceutical development.
  • Proficient computer skills, including Microsoft Word, Excel, PowerPoint, SharePoint, and Smartsheet.
  • Strong organizational, verbal, and technical written communication skills, with the ability to manage multiple tasks.
  • Excellent interpersonal communication skills, enabling effective collaboration within a team environment.
  • Adaptability to rapidly changing environments and circumstances, demonstrating flexibility.
  • Strong troubleshooting and problem-solving abilities.


Contact your Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Daniel, directly:

Email: drichey@harbasolutions.com

Phone: 857-232-0909



About Harba Solutions:

Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.



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