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Quality Assurance Specialist

Quality Assurance Specialist

Accentuate StaffingCary, NC, US
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Accentuate Staffing is partnering with a well-established biopharmaceutical company who is hiring for Quality Assurance Specialists to join their team. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate has hands-on quality assurance experience, strong knowledge of quality management principles, and the ability to collaborate effectively across scientific and operational teams.

Responsibilities :

  • Review and approve client materials, validation documentation, facility forms, and completed inventories in alignment with SOPs, client specifications, and regulatory requirements.
  • Oversee the release, transfer, shipment, and destruction of biological materials, ensuring accurate labeling and documentation.
  • Participate in internal audits, generate client reports, and support special projects to maintain compliance and continuous improvement.
  • Ensure strict adherence to safety regulations when handling potentially infectious or biohazardous materials, following OSHA and HIPAA guidelines.
  • Collaborate effectively with Operations and Management teams to maintain high-quality standards and timely workflows.
  • Utilize LIMS and other quality management tools to track, document, and communicate QA outcomes efficiently.

Requirements :

  • Bachelor’s or associate degree in life sciences, healthcare, quality management, or a related field—or equivalent combination of education and experience.
  • One year, or more, of biorepository or laboratory experience, with a minimum of 1–2 years in a QA or quality management role preferred.
  • Strong understanding of quality management systems (QMS), GMP regulations, and quality assurance principles.
  • Proficiency in LIMS and other computer systems; ability to prepare quality and statistical reports is highly desirable.
  • Exceptional organizational, time management, and communication skills, with the ability to maintain confidentiality.
  • Demonstrated ability to collaborate, lead by example, and support operational excellence in a fast-paced laboratory or pharmaceutical environment.
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    Quality Assurance Specialist • Cary, NC, US

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