Scientific Quality Assurance Auditor
Kelly Services - Pembroke Pines, FL

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Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Qualit Associate Scientist in a prestigious Fortune 500® pharmaceutical company located in Pembroke Pines, Florida.

By working with Kelly in this role, you would be eligible for:
- A competitive hourly pay rate with weekly checks
- Access to newly expanded Medical Plan options
- Online continuing education via the Kelly Learning Center
- Several employee discounts
- And more!

This is a 12 month temporary position at 40 hours per week.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( gaut985@kellyservices.com or call 732-246-1396 x 203) however your resume must be received via the “submit now” button included within.

Scientific Quality Assurance Scientist is responsible for quality assurance duties relating to studies performed under GLP/GMP/CLIA compliance. Responsibilities: - 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. Qualifications: - Bachelors degree or equivalent in a basic science field; with zero to two years related experience and/or training; or equivalent combination of education and experience. - 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. - Excellent organizational, analytical, planning, and computer skills. Effective verbal and written communication skills. - Comfortable in a rapidly changing environment. Self-motivated; ability to work independently and work as constructive team member - 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. - Detail oriented, multi-tasking, with an emphasis successful data delivery. - A drive to build on current knowledge and experience. Ability to analyze and recommend enhancements to processes, procedures and systems.

Kelly Services - 15 months ago - save job - block
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...