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 /.
- 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.
- 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.
- Develop, validate, and implement new calculation formulas, product specifications, and stability profiles in LIMS for NPIs, customer and regulatory demands, and process improvements.