Senior Quality Management Systems Specialist in Morris Plains, NJ from Real Staffing, US

Quality Systems Specialist II / Senior Quality Management Systems Specialist

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.

Job Description
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.

Key Responsibilities

• 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).

Key Qualifications

• 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.