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Medical Technologist/Technician Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
JOB RESPONSIBILITIES:
- 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.
JOB QUALIFICATIONS:
- Bachelor's degree or equivalent in a basic science field; with 3+ year's related experience and/or training; or equivalent combination of education and experience. FOCUS SHOULD BE IN HEMATOLOGY (SCIENTIST OR MED TECH).
- 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.
- Excellent Communication/Writing skills, experience in regulated manufacturing environment (Diagnostic/Lab).
DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.
RECRUITER: Mardie dela Cruz
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
MONJOBJ2WSEMW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Miami, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung