Real Staffing
Real Staffing is currently working with our large pharmaceutical client to hire a Quality Control Analyst for a contract role. The ideal candidate will be responsible for coordinating and executing stability studies to meet regulatory requirements for commercial biotech products. Candidate will also support Technical Registration Documents and other regulatory document updates. Additionally, support will be required for related investigations along with internal and external audits.
Maintenance of the QC Stability laboratory areas and QC Stability documentation will also be required. Position Duties and ResponsibilitiesSetup and initiate stability studies in LIMS and physically in the stability chambers. Support stability pulls with the team to pull the appropriate inventory from the stability chambers and submit to the labs for stability testing. Support management of stability, standards and controls inventory including periodic inventory checks, sample disposals, and close out of stability studiesFollow GMP SOPs for management of stability, standards and controls program.
Support lab and equipment maintenance including equipment cleaning, commissioning/decommissioning activitiesSupport OOS investigations related to stability, standards and controls. Support statistical analysis of stability data and OOT investigations Support maintenance of Controlled Temperature Environment (CTE) equipment. Support regulatory audits including internal compliance audits. Collaborate with groups within QC and outside of QC for management of the stability program for a product and OOS investigations.
Requirements/Preferences: Education Minimum Requirement Bachelor’s DegreeExperience with a cGMP and global regulatory compliance organization is required. Experience with Reference Material Programs or Stability Programs and data evaluation per ICH Guidance is highly desirableExperience with JMP software for statistical analysis and LIMS highly desirableFamiliarity with the client’s products and manufacturing processes highly desirable. Experience with equipment and analytical method validation is highly desirableTechnical writing skills are required.
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