Aptask Global Workforce (AGW) is seeking a Quality Assurance Manager - Computer Systems Validation - Remote for a position with a Global Biotechnology Company located in Nashville, TN. This is a 6+ month contract opportunity. Summary: This role focuses on Quality Assurance for computerized systems within a GxP-regulated environment. The ideal candidate will leverage mandatory Computer Systems Validation experience to review and approve validation deliverables, manage change controls, and ensure compliance with GMP, GLP, and Google Cloud Platform regulations. This is a collaborative role requiring strong communication and proactive engagement with cross-functional teams, with a preference for candidates who can work PST hours.
Responsibilities: - Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
- Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
- Serve as a Change Agent and advocate for the Risk Based Validation program
- Act as SME for multiple Quality processes (e.g. Deviations, CAPA)
- Review and Approve SOPs and associated documents
- Review/Approve Periodic Reviews for GxP Systems
- Perform software Supplier Evaluations as needed
- Support project initiatives and process improvements
- Present on topics or issues to management
- Support audit & Inspections requests as needed
Requirements: - Bachelor's degree in a technical or related subject and 5+ years of direct experience, or equivalent experience in lieu of a degree
- Mandatory experience in Computer Systems Validation within a regulated industry (e.g., Biotechnology, Medical Device, Aerospace)
- Proven experience with Validation and Change Control
- Ability to interpret and apply GMP, GLP, Google Cloud Platform, and GPvP regulations
- Strong documentation, operational, and guideline compliance experience
- Excellent organizational skills and ability to follow assignments through to completion
- Strong communication (both written and oral), facilitation, and presentation skills
- Ability to work independently and interact effectively with various levels of management
- Ability to lead and influence staff outside the QA organization
Desired skills: - Experience with Risk Based Validation and/or strong Computer System Assurance (CSA) knowledge
- Experience working with Veeva or Safety Systems
- Knowledge of industry-wide regulatory systems
Pay range: up to $61.96 per Hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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