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cGMP Quality Specialist


PayCompetitive
LocationOak Ridge/Tennessee
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: S8hb5L2sGjD2
      Employer Industry: Pharmaceutical Manufacturing

      Why consider this job opportunity:
      - Opportunity for contract work with a duration of 3 to 4 months
      - Hybrid work option available, providing flexibility between onsite and remote work
      - Work in a dynamic team environment focused on innovative solutions
      - Engage in meaningful work that impacts the production of radioisotope products
      - Collaborate with peers and external customers to enhance quality assurance practices

      What to Expect (Job Responsibilities):
      - Interpret quality assurance requirements from regulatory guidelines and apply them in work procedures and documents
      - Review production batch records and approve radioisotope products for distribution
      - Develop technical procedures and documents while implementing QA requirements
      - Maintain up-to-date regulatory filings with agencies, including a Drug Master File
      - Conduct cGMP training and assist in non-conformance processing

      What is Required (Qualifications):
      - Bachelor's degree in Science, Quality Assurance, or a related field
      - Minimum of five years of relevant quality experience
      - Working knowledge of current Good Manufacturing Practices (cGMP) for drug manufacturing
      - Ability to obtain and maintain a clearance from the Department of Energy
      - Must pass a pre-placement drug test as this is a Workplace Substance Abuse (WSAP) testing designated position

      How to Stand Out (Preferred Qualifications):
      - Strong computer and organizational skills with multitasking ability
      - Experience with quality-related analytical methods such as gamma spectroscopy
      - Background in radioisotope production and facility design for manufacturing
      - Knowledge of radioactive decay calculations
      - Proven track record of collaborating with internal and external organizations

      #PharmaceuticalManufacturing #QualityAssurance #ContractJob #HybridWork #cGMPCompliance

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  • About the company

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