QAV Technician Specialist

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Join to apply for the QAV Technician Specialist role at Real

This range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$40.00/hr - $45.00/hr

The QA Validation Technician is a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle a selected workstream from commissioning, qualification and validation (CQV) activities. Specialist/Technician support covers selected aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in software solutions or manufacturing or testing operations

• Support in data review of validation documents
• Quickly recognize, implement, and enforce compliance with applicable regulations,
• Implement best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy).
• Facilitate cross-functional teamwork with workstream's stakeholders including harmonization and alignment of own QA Validation deliverables with U.S. QA Validation Management, Global Quality Operations and cross-functional Leadership.
• Support in data review for pre- and post-execution deliverables of validation related documents which may focus on company's assets such as computerized systems, production process equipment, laboratory method studies, facilities and IT infrastructure in scope for GxP matters.
• Support in review of Procedures such as Operational, Maintenance Cleaning documents (OMC) with focus on quality requirements and good documentation practices.
• Support in data review for deliverables from Quality Management Systems
• Supports Project Management with Quality focus, Data Management, Digitalization initiatives, Business Continuity and Archival Business Processes
• Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point.
• Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings.
• Understanding of Validation Lifecycle Pillars, which may include equipment/asset lifecycle management, equipment qualification execution, equipment operation, equipment maintenance, workflows incl. GxP Computerized System Validation (CSV), Qualification phases.
• Understanding of regulatory requirements and auditing.
• Peer coaching/training experience showing organizational and interpersonal skills.
• Understanding and experience with cell-based production processes, cell-based and molecular-based analytical testing in the field of Cell and Gene Therapy.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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• Seniority level
  
  Not Applicable

• Employment type
  
  Contract

• Job function Science
• Industries Manufacturing

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