Senior Quality Assurance Validation Specialist

Regeneron Pharmaceuticals•Rensselaer, NY

18d•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you 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 offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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
Full cleanroom attire (Examples may include: 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

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
Coordinates with other departments or outside contractors/vendors to complete validation tasks
Executed 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; analyzed data to inform packaging design and handling recommendations
Programs humidity and pressure sensors and interpreted 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