Senior Quality Assurance Validation Specialist

About the role

As the Senior QA Validation Specialist, you will validate and qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow, and implement company manufacturing standards policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Generate, execute and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyze the results of testing and determine the acceptability of results against pre-determined criteria
• Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
• Review, edit and approve deviation notifications, deviation investigations, and corrective actions
• Review, edit and approve change controls, SOPs, reports and other documentation
• Coordinate with other departments or outside contractors/vendors to complete validation tasks
• Execute real-world and simulated transport 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 to inform packaging design and handling recommendations
• Program humidity and pressure sensors and interpret datasets to support test plans and root-cause analysis
• Apply ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Perform small-parcel and palletized-load qualifications, including test planning, execution, and reporting
• Gowning and environment: full cleanroom attire (including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA); ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Requirements

• Requires B.S in life sciences or related field; may substitute proven experience for education requirement
• QA Validation Specialist: 4+ years of experience
• Sr. QA Validation Specialist: 6+ years of experience
• Level will be determined based on experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

Pay

Salary range (annually): $67,400.00 - $128,700.00