What are the responsibilities and job description for the Quality Specialist - III (Senior) position at Net2Source (N2S)?
Join a Global Leader in Workforce Solutions - Net2Source Inc.
Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500 . Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.
Title: Senior Specialist, Quality - Veterinary Biologics (Batch Safety Test Exemptions)
Duration: 24 Months
Location: Remote (Travel up to 20% to other Client Animal Health sites within the U.S.)
Position Summary
The Senior Specialist, Quality, will lead preparation, execution, and maintenance of Animal Batch Safety Test Exemption submissions and associated internal controls for USDA-licensed veterinary biologics. This senior role requires deep expertise in biologics or vaccine manufacturing/testing, strong regulatory writing capabilities, and proven ability to manage complex cross-functional projects across Quality, Operations, Planning, Regulatory, and Pharmacovigilance.
Qualifications
• Bachelor's degree in biological sciences, microbiology, veterinary medicine, pharmacy, or related field; advanced degree preferred
• Minimum 5-8 years' experience in quality, regulatory, or manufacturing support for veterinary biologics/vaccines
• Experience with batch release, stability, inactivation studies, or pharmacovigilance
• Demonstrated experience preparing regulatory submissions, technical reports, or protocol/study summaries
• Strong working knowledge of USDA/APHIS regulations and relevant guidance (VSMs, 9 CFR 113/116, VICH GL50/GL59, APHIS forms)
• Excellent technical writing skills with strong attention to detail
• Proficiency with document management systems and regulatory tracking tools (e.g., Reliance)
• Ability to review/interpret laboratory data (API, potency assays, purity tests)
• Strong project management and stakeholder coordination abilities
Core Competencies & Behaviors
• Analytical thinker comfortable with complex technical datasets
• High attention to detail and regulatory compliance
• Skilled communicator able to translate technical data into strong regulatory rationale
• Collaborative, credible across Quality, Regulatory, Operations, Planning and PV
• Organized, proactive, and deadline-driven
Key Responsibilities
• Lead full exemption submission process per Work Instruction for Requesting Laboratory and Target Animal Batch Safety Exemption
• Evaluate product eligibility using manufacturing history, safety results, purity testing, serial history, and PV record
• Assemble and verify pre-report elements such as OP, inactivation studies, ISS, and production records
• Compile and summarize LABST and TABST descriptions and results including APHIS Form 2008 data
• Prepare summaries of sterility, mycoplasma, and OP-specified purity tests
• Propose and justify maximum antigen content and potency limits for OP/SO updates
• Partner with Global Pharmacovigilance to produce Product Safety Assessments
• Compile documentation for manufacturing history, technology transfers, CVB-IC inspection reports, and serial release testing
• Draft high-quality exemption reports and appendices for CVB submission
• Coordinate revisions to Outline of Production (OP) and Special Outlines (SO)
• Ensure internal documentation (bench records, PV data, observations) is complete and audit-ready
• Implement and maintain post-approval obligations including annual PV reporting through Reliance Obligations module
• Monitor antigen content specification and revisit if adverse events arise
• Maintain/update internal notification and escalation procedures for exempted products
• Manage meetings, timelines, risks, and cross-functional deliverables
• Train and mentor Quality and cross-functional SMEs on exemption requirements
Why Work With Us?
At Net2Source, we believe in more than just jobs—we build careers. We celebrate diverse perspectives, empower talent at all levels, and offer a collaborative environment where your ideas matter.
Our Commitment to Inclusion & Equity
We are an equal opportunity employer committed to fairness, respect, and opportunity for all.
Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by SIA
• INC 5000, eight consecutive years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1
Ready to Level Up Your Career?
Click Apply Now and let's make it happen.
Salary : $55 - $60
