Yoh has a long term contract opportunity for a Quality Assurance Scientist to join our client, a world leader in the pharmaceutical industry, located in Pembroke Pines, FL.
- Responsible for quality assurance duties relating to studies performed under GLP/GMP/CLIA compliance.
- Participates in the development, implementation, and maintenance of quality systems per GLP, GMP and CLIA regulations.
- Reviews quality related documents, including but not limited to: study protocols, study reports, OOS investigations, validation reports, and other relevant documents as needed.
- Develops and reviews controlled documents and procedures pertinent to quality assurance and operations activities.
- Works cross functionally in identifying and resolving quality issues as they present themselves.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Supports the preparation and coordination of inspections by regulatory authorities and clients.
- Assists with the conduct of quality audits both internally and externally per site SOPs and Quality Plan.
- Trains employees on revisions of procedures and the implementation of new procedures.
- Bachelor's degree or equivalent in a basic science field; with zero to two (0 - 2) years related experience and/or training; or equivalent combination of education and experience.
Discover all that's possible with Yoh. Apply now.
- Knowledge and understanding of validation concepts.
- Familiarity with FDA (GLP/GCP/GMP), CLIA, and international regulations (OECD and ICH).
- Previous pharmaceutical, biotechnology, or clinical diagnostic industry experience in QA or regulatory compliance and experience with genetic test methodologies.
- Experience in a GLP, GMP, or CLIA environment.
- Familiarity with LIMS system and laboratory databases.
- Knowledge of molecular biology techniques, including DNA and RNA isolation, qPCR, DNA sequencing, Southern / Northern Blots, and Gene Expression Profiling.
Recruiter: Natane Peslis
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: SCIENTIFIC; J2W: CLINICAL
Yoh Services, LLC
- 2 years ago - save job
Yoh Company is a unit of Yoh, one of the largest staffing services firms in the United States with more than 550 million USD in total...