SiteQualityControlAnalyst

**_Role Description_** **POSITION SUMMARY** The Quality Control analyst reports to the QC Manager and will be responsible for all QC test activities including but not limited to testing of Incoming materials, In Process Materials, Intermediate, API and Stability Samples, Method Transfer and Validation and Data Review. The role will maintain the Quality System for QC; ensuring that Standard Operating Procedures are in place and that compliance with cGMP is maintained through ongoing training and process review. **POSITION RESPONSIBILITIES** **** **Key objectives of this position include:** **** 1. Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required. 2. Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases. 3. Preparation & review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP’s, calibration procedures, Analytical Test Records, and miscellaneous protocols). 4. Testing of Raw Material, Intermediates, API’s and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program. 5. Testing of Swab and Rinse samples and visual inspection of equipment after cleaning 6. Sampling and testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring). 7. Review and accuracy check of Analytical Data 8. Performing Own Training activities (reading acknowledgments, attendance at training events, online training completion). 9. Active participation in laboratory Tier meetings. 10. Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities. 11. Participation in Instrumentation calibration & maintenance. Responsi