- Job date: Thu, 12 Nov 2020 08:59:43 GMT
- Expected salary: $42 per hour
- Job title: Senior Quality Management Systems Specialist
- Company: Real Staffing
- Location: Morris Plains, NJ
Location: Morris Plains, NJ
Duration: 4 Month Contract to Start
Pay Rate: Up to $42hr depending on relevant experience
Benefits: Real staffing offers medical dental, vision, 401K, voluntary life insurance, short term/long term disability.
A well-known Pharma company is looking to hire a Senior Quality Management System Specialist. Responsibilities include executing daily activities with a focus on the Calibration and Change Control systems with some responsibilities related to Complaints and Risk Management. This position ensures compliance with established and approved quality systems.
- Maintain processes in Veeva Quality Management system for Quality Systems including but not limited to Document Control and Change Control.
- Maintains current procedures and executes quality functions within the Change Control, Calibration, Document Control and Complaint processes.
- Maintains and distributes quality system metrics following established procedures.
- Reviews change control, document change controls, calibration and other quality records for accuracy and conformance to established guidelines, and procedures.
- Advises and responds to queries on quality systems.
- Coordinates changes to the applicable Quality System procedures by reviewing changes for applicability, interfacing with internal approval SMEs and management, facilitating functional meetings, and acting as a liaison to bring documentation to closure.
- Reviews and approves calibration, preventative maintenance records and work orders.
- Completes Quality Impact Assessments for document change controls (DCC).
- Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred
- 8 years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience
- Experience in Quality Assurance functions and Quality Compliance functions required.
- Strong customer service philosophy required.
- Scientific writing experience preferred
- Experience with Veeva Vault Quality strongly preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.