Quality Systems Specialist II
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
The Senior Quality Management System Specialist executes daily activities and maintains 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.
ESSENTIAL JOB FUNCTIONS* (PRIMARY 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.
• Identifies improvements by analyzing the current business/system processes and recommending improvements within the scope of their influence.
• Reviews quality system information for accuracy and conformance to established guidelines and procedures.
• Reviews and approves calibration, preventative maintenance records and work orders.
• Completes Quality Impact Assessments for document change controls (DCC).
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Excellent written and verbal communication skills required, including responsible business communication.
• Scientific writing experience preferred.
• Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
• Strong customer service philosophy required.
• Must be proficient with all MS Office applications.
• Experience with Veeva Vault Quality strongly preferred.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred, with 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.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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