Qa Validation Specialist

Job Title: QA Validation Specialist

Company: Novozen Health Care

Location: Rensselaer, New York

Employment Type: Contract

• Generate, execute, review, and approve qualification and validation protocols, summary reports, and associated documentation in accordance with regulatory requirements, SOPs, specifications, and acceptance criteria.

• Analyze testing results and determine compliance with predefined acceptance criteria.

• Investigate validation issues, troubleshoot problems, and recommend corrective actions or process improvements.

• Review, edit, and approve deviation notifications, deviation investigations, corrective actions, and change controls.

• Review and approve SOPs, reports, and other quality documentation.

• Coordinate validation activities with internal departments and external contractors or vendors.

• Execute real-world and simulated transportation studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials.

• Conduct temperature mapping for controlled environments and distribution lanes.

• Program and deploy instrumentation to capture vibration and shock profiles, analyze data, and recommend packaging design and handling improvements.

• Program humidity and pressure sensors and interpret data to support test plans and root-cause investigations.

• Apply ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification.

• Perform small-parcel and palletized-load qualification activities, including test planning, execution, and reporting.

• Comply with cleanroom gowning procedures, including wearing required protective attire and following applicable hygiene and sanitization requirements.

• Bachelor's degree in Life Sciences or a related field; equivalent proven experience may be considered in place of formal education.

• Minimum of 4 years of relevant experience in QA validation or a related quality function.

• Experience generating, executing, reviewing, and approving qualification and validation protocols and reports.

• Knowledge of deviation investigations, corrective actions, change controls, SOPs, and regulatory compliance.

• Hands-on experience with transportation studies, packaging qualification, temperature mapping, or cold-chain shipping validation is highly relevant.

• Familiarity with ASTM and/or ISTA standards, shock and vibration testing, and environmental sensor data analysis.

• Ability to investigate technical issues, analyze test results, and recommend corrective or preventive improvements.

• Ability to wear full cleanroom attire and comply with gowning requirements, including removing jewelry, makeup, and nail adornments when required.

Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.