Senior Quality Assurance Validation Specialist

About the role

The Sr. QA Validation Specialist will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position contributes to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits and approves change controls, SOPs, reports and other documentation
• Covers real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
• Conducts temperature mapping for controlled environments and distribution lanes
• Programs and deploys instrumentation to capture vibration and shock profiles; analyzes data to inform packaging design and handling recommendations
• Programs humidity and pressure sensors and interprets datasets to support test plans and root-cause analysis
• Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Performs 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)
• Ability to remove jewelry, makeup and nail adornments when wearing cleanroom attire

Requirements

• Bachelor's degree 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

Qualifications

• 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

Skills

• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits and approves change controls, SOPs, reports and other documentation
• Covers real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
• Conducts temperature mapping for controlled environments and distribution lanes
• Programs and deploys instrumentation to capture vibration and shock profiles; analyzes data to inform packaging design and handling recommendations
• Programs humidity and pressure sensors and interprets datasets to support test plans and root-cause analysis
• Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Performs 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)
• Ability to remove jewelry, makeup and nail adornments when wearing cleanroom attire

Benefits

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

Pay

$67,400.00 - $128,700.00 annually

Schedule

Monday-Friday, 8am-4:30pm