Quality Specialist

San Jose, CA
United States

inVentiv Health Clinical

10000+ employees

inVentiv Health offers a complete range of clinical, commercial and consulting solutions for every stage of the lifecycle. From small biotech enterprises with promising compounds to pharmaceutical giants with established brands, the Company has the breadth of capabilities to support a countless range of clients and needs. With experts in every aspect of product development, launch and commercialization, the Company builds multidisciplinary teams to provide comprehensive solutions to the challenges clients face

The Spirit of inVention is the philosophical foundation of our business. It is the heart of who we are. It's how we solve problems. The Spirit of inVention is the philosophy underpinning our connection with clients and each other, leading to accelerated performance, enhanced value, and improved lives.
Our core values are Strategic Collaboration, Extraordinary Outcomes, and Shared Accountability

Company Info

Job description

A Quality Specialist is needed for a long-term contract position at a major biotech company in Northern California - Partner with inVentiv Health and TEAMSCI on this awesome opportunity! 

Job Duties: 

1. Maintain and monitor document control system and equipment record status in compliance according to CAP/CLIA/CA/NY and other regulatory agencies.
2. Prepare for and participate in internal audits of the CLIA lab and supporting systems. Maintain schedule of planned quarterly audits.
3. Provide assistance to the CLIA lab for all CAPA and nonconformance investigation and resolution. Oversee the CAPA and Nonconformance management systems.
4. Provide assistance to maintain high quality standards and change control during new test launch, LIMS updates, and all process changes.
5. Maintain training and competency records. Ensure new hires have completed all required tasks.  Provide assistance to distribute and collect Continuing Education records.  Assist in development of updates to the training and competency program.
6. Support administration of the environmental monitoring system. Provide user assistance and back up support to engineering services during upgrades or moves.
7. Assist with / manage projects to improve the effectiveness and efficiency of the existing quality system
8. Maintain records and proper documentation for Quality Meetings including preparation and distribution of performance metrics.
9. Communicate and escalate any issues or concerns to the QA Manager.

Education and Experience:
• Bachelor’s degree in Chemistry, Biological Sciences or related field, or equivalent combination of education and work-related experience.
• 1 to 2 years in the diagnostics or pharmaceutical industry dealing with quality.
• Preferred: 3 to 4 years in the diagnostics or pharmaceutical industry dealing with quality.
• Preferred: Experience working with CLIA, CAP, and NYS regulations / standards for operation of a Clinical Laboratory
 

Company Description

inVentiv Health Clinical is seeking to fill this position on behalf of a client company. inVentiv Health Clinical, LLC, an inVentiv Health, Inc. company, is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace. inVentiv Health Clinical is a global CRO and leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bio analytical services, and strategic resourcing from a single clinical professional to an entire functional team. With approximately 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value. We offer exciting career paths for clinical research professionals, including permanent and contract opportunities.

Work location: San Jose, CA

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