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Quality Assurance Specialist

2 months ago


Princeton, New Jersey, United States Clinical Resource Network (CRN) Full time

Position Overview:

We are seeking a dedicated Quality Assurance Specialist to oversee compliance within our clinical manufacturing processes. This role is integral to maintaining the highest standards of quality and regulatory adherence.

Key Responsibilities:

  • Ensure compliance with Good Manufacturing Practices (GMP) for outsourced clinical production, packaging, labeling, and testing activities.
  • Conduct thorough QA reviews of manufacturing records for active pharmaceutical ingredients (API) and drug products to verify accuracy and compliance with regulatory standards.
  • Review clinical packaging documentation to ensure it meets Otsuka's quality and GMP requirements.
  • Analyze analytical test results and raw data to confirm they meet established specifications and are documented appropriately.
  • Evaluate quality events, deviations, investigations, and change controls to ensure proper handling and resolution.
  • Communicate project and supplier issues to management to facilitate timely resolutions.
  • Collaborate effectively with vendors and internal departments to ensure adherence to both local and global regulatory requirements.
  • Utilize the TrackWise Digital eQDMS System for batch-related information entry and workflow management.
  • Maintain comprehensive GMP records, including document storage, archiving, and retrieval.
  • Assist in compiling data for R&D metrics, dashboards, and management reviews.
  • Support activities aimed at ensuring readiness for inspections.
  • Contribute to process improvement initiatives within the TrackWise Digital Quality R&D Division.

Qualifications:

  • Bachelor's degree in Engineering, Chemistry, Biology, or a related scientific field.
  • 2-5 years of relevant experience in the pharmaceutical or medical device industry, particularly in Manufacturing, Quality Assurance, or Quality Control roles.
  • Proficient in managing multiple tasks independently.
  • Strong interpersonal skills to effectively resolve issues with internal stakeholders and GMP vendors.
  • Experience with MS Office Suite (Word, Excel, PowerPoint).
  • Familiarity with TrackWise Digital or similar electronic Quality Document Management Systems.
  • Excellent communication skills, both verbal and written.
  • In-depth understanding of GMP requirements and the drug development lifecycle.
  • Strong analytical and problem-solving abilities.
  • Experience in quality oversight of R&D and clinical product manufacturing and packaging.

If you possess the necessary qualifications and are interested in this opportunity, we encourage you to explore this role further.

About Clinical Resource Network (CRN):

CRN, a division of Solomon Page, specializes in providing clinical research and talent solutions for the pharmaceutical, biotech, and medical device sectors. We focus on building long-term partnerships and offer a range of services including contract staffing, project staffing, consultative services, and full-time placements.

We look forward to your interest.