Quality Control Analyst Iii
Current▪ Plan and adjust the day-to-day testing schedule for the QC Lab in collaboration & coordination with other personnel and departments to efficiently manage project prioritization and resource allocation: ▫ QC Analysts / Manufacturing Scheduler / Buyers / Stability Coordinator / QC Metrology Specialist / Technical Services Specialists / QC Technical Transfer Analysts ▪ Lead and/or contribute to multiple tiers of start and end-of-day cross-functional meetings to receive and relay information on the progress of high priority QC deliverables and KPIs:▫ On-time release of raw materials and finished products to guarantee high customer service. ▫ CAPA, Deviation, and ALIR completion within specific turnaround times. ▪ Ensure QC Analyst laboratory and documentation work is compliant with cGMP & GDocP standards, and established pharmacopeial (USP, Ph. Eur., BP), Customer, FPS, RM, and QAIP specifications. ▪ Ensure QC Metrology calibration and maintenance documentation follows applicable manufacturer/instrument SOPs and cGMP requirements. ▪ Review OOS and questionable results within Laboratory Investigation Reports (ALIRs) or Deviations, as applicable. Propose and review hypothesis testing, re-measurement and re-testing protocols. Mitigate recurring errors through implementation of CAPAs. ▪ Develop, validate, and implement new calculation formulas, product specifications, and stability profiles in LIMS for NPIs, customer and regulatory demands, and process improvements. ▪ Participate in internal and external (FDA, Health Canada, Customer) audits to ensure compliance with new and existing regulatory & company quality standards. ▪ Develop/review and implement new SOPs from regulatory feedback with regards to data integrity, instrument procedures, physical documentation, and electronic data. ▪ Develop, review, and troubleshoot new and existing analytical procedures and test methods for instruments, detectors, and software.
