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Quality Assurance Technical Data Reviewer

  • Permanent
  • Anywhere

Website Actalent

Actalent

Company : Actalent

Country: United States

Location : Lenoir, North Carolina

Post: Sun, 19 Sep 2021 05:21:56 GMT

Expires: Tue, 19 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

DESCRIPTION:Our client a sterile injectable manufacturer located in Lenoir, NC is seeking a Data Reviewer for their Microbiology Department to support the reviewing and approving of technical documents such as method validation/verification protocols and reports, raw material testing, release and stability test data sheets and laboratory notebooks. Job Responsibilities Review documents that support incoming raw material and component release. Audit and ensure all activities are performed in compliance with cGLP/CGMP requirements. Review investigations on studies that have unusual results, and on out-of-trend and out-of-specification results. Write, review, and update standard operating procedures and department policies as needed.SKILLS:Quality assurance, microbiology, GMP, biology, documentation, release testing, SOPs, vitek, sterility testing, endotoxinTOP SKILLS DETAILS:Quality assurance, microbiology, GMPADDITIONAL SKILLS & QUALIFICATIONS:Education Requirements Microbiology or related scientific discipline with approximately 3 + years of experience in a laboratory settingExperience Requirements Must be excellent in attention to detail. Must have working knowledge of FDA regulations/guidances, good manufacturing practices, and ICH and USP/NF guidelines. Must be familiar with US Pharmacopeia. Prefer knowledge of Vitek Prefer knowledge of MODAEXPERIENCE LEVEL:Expert Level ABOUT ACTALENT: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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