QA Validation Specialist

Job Responsibilities Generate, execute, review, and approve qualification and validation protocols, summary reports, and associated documentation in accordance with regulatory requirements, SOPs, specifications, and acceptance criteria. Required Qualifications Bachelor's degree in Life Sciences or a related field; equivalent proven experience may be considered in place of formal education.

Job Title: QA Validation Specialist

Company: Novozen Health Care

Location: Rensselaer, New York

Employment Type: Contract

Job Responsibilities

• 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.

Required Qualifications

• 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.

Pay Scale:
Anticipated hourly pay range: $40-44/hr on W2. Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

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.