Senior Quality Control Analyst, QC Technical Resources

Job SummaryProvides scientific and technical, support to the Quality Control Technical Service group while coordinating all aspects of the site's stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers, verifications, and qualifications activities.ResponsibilitiesDevelop and maintain stability protocols, reports, and other related documentation to support the stability program.Manage stability chambers, including qualification, monitoring, and capacity planning.Ensure timely pull points, testing, data review, and reporting for all stability studies.Trend stability data, identify OOT/OOS signals, and support investigation related to stability samplesAuthor, review, and revise QC SOPs, test methods, and technical documentationDevelop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC.Skills requiredDeep knowledge of GMP regulations and advanced laboratory techniques.Strong Knowledge of in Empower and OpenLab chromatography software.Strong understanding of stability program requirements (ICH Q1A-Q1E).Familiarity with GMP, data integrity principles, and regulatory expectations.Strong organizational skills and ability to manage multiple studies and timelines.Excellent documentation, communication, and cross-functional collaboration abilities.Knowledge of method validation or lifecycle management.Ability to analyze data trends and contribute to technical investigations.Familiarity with regulatory guidelines (ICH, FDA, EMA)Maintain audit-ready documentation and support internal and external inspections.Well-organized, capable of multi-tasking and working on complex problems with sound scientific judgementExcellent data analysis skills with attention to detail and interpretation of resultsExcellent written and oral communication skillsExperience with computer software such as WORD, EXCEL and chromatographic workstation systemsEducation and experienceBS in Chemistry, Biochemistry, Analytical Chemistry or related fieldMinimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotechPhysical RequirementsProlonged periods of sitting at a desk and working on a computerPotentially prolonged periods standingMust be able to lift up to 15 pounds at timesCompensationThe base salary for this role starts at $114,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws.