Quality Assurance Specialist With Experience In GLP

  • Permanent
  • Anywhere

Website Actalent


Company : Actalent

Country: United States

Location : Deerfield Beach, Florida

Post: Sun, 19 Sep 2021 05:28:21 GMT

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

Apply Job : Apply Online

—————————— Job Description ——————————

Our client is urgently hiring for a GLP QA SpecialistDESCRIPTION:Description: The QA Specialist will implement, maintain and enhance quality procedures and systems at the Deerfield Beach laboratory to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications. The selected individual will report to and work with the QA Manager for the Bioanalytical business unit at HQ and will manage the transfer and implementation of company-wide policies, procedures, and standard operating procedures (SOPs) to the local site. He/she will maintain and safeguard compliance-related documents such as SOPs, employee training records, audit reports, and detailed notes. The selected individual will ensure that the laboratory practices remain compliant with ever-changing government guidelines and industry standards. In particular, since the local site will focus on genomics assays where federal guidelines are not always well defined, the QA Specialist will provide recommendations to managers and study directors regarding best practices for conducting genomics assays following industry consensus, informal FDA guidelines, and guidance for related non-genomics laboratory assays. The QA Specialist will provide quality training to staff and will keep track of and report quality issues to supervisors, study directors, and management, as appropriate. He/ she will conduct quality audits internally as well as for current and potential vendors of Frontage. The QA Specialist will host external regulators and clients during audits of the local facility.ADDITIONAL SKILLS & QUALIFICATIONS:Requirements: -The position requires a B.S. or M.S. degree in a scientific discipline that is relevant to pharmaceutical drug discovery and genomics.-Three or more years of full-time work experience in an academic or commercial laboratory focused on genomics, molecular biology, cell and gene therapy, immunology, or related discipline. -An additional 3 years of work experience in the area of quality assurance, particularly as related to maintaining compliance with GLP or GCLP guidelines and FDA guidance related to NGS or bioanalytical assay development is highly desirable but not required. -A working knowledge of GLP, GCLP, and Bioanalytical assay validation is essential. -The selected individual will possess excellent communication skills including proficiency in workplace presentations, technical writing, editing, grammar, spelling, and note-taking, and transcription. -A fervent desire to establish or grow in a career track in Quality Assurance as it applies to the Drug Discovery industry is essential.EXPERIENCE LEVEL:Entry 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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