Quality Control Specialist

Regeneron Pharmaceuticals•Rensselaer, NY

5d•$67,400 - $110,000•Onsite

About The Position

Quality Control External Testing is currently looking to fill a QC Specialist position with a 1st shift, Monday-Friday, 8:00am – 4:30pm schedule. This position performs data review of analytical test results to support QC External Testing operations. In this role, a typical day might include the following: Conduct comprehensive data review for Release, In-Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards. Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation. Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes. Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). Monitor testing compliance with established laboratory procedures, test methods, and approved protocols. Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP-oriented culture. Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data. Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE-SDS. Engage with team members to implement continuous improvements to data review processes and methodologies. Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs. Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines. Support the development and review of QA events, deviations, and investigations as required. Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance.

Requirements

BS/BA in a scientific field and 2 years of related experience or equivalent combination of education and experience.
Experience in a GMP setting
Strong ability to achieve thoroughness and accuracy when performing tasks
Strong prioritization / organizational skills and are detailed-oriented.
Capability to adjust to shifting priorities, manage multiple tasks and meet deadlines
Excellent written and oral communication skills

Nice To Haves

Ability to effectively communicate issues and ideas with direct reports, peers, and with management

Responsibilities

Conduct comprehensive data review for Release, In-Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards.
Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation.
Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes.
Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
Monitor testing compliance with established laboratory procedures, test methods, and approved protocols.
Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP-oriented culture.
Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data.
Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE-SDS.
Engage with team members to implement continuous improvements to data review processes and methodologies.
Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs.
Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines.
Support the development and review of QA events, deviations, and investigations as required.
Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance.