QC Senior Specialist, Lab Support

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The QC Senior Specialist, Lab Support primary focus will be supporting all day to day routine maintenance and calibration activites for QC laboratory equipment which are in a validated state in the cGMP Laboratories at AAMF. This will also require support for all associated laboratory software.
This individual will be a high functioning, highly adaptable resource for the Laboratory Support Equipment team and will conduct activites in alignment with site SOPs and regulatory standards for laboratory equipment qualification and maintenance.

YOU WILL BE RESPONSIBLE FOR:

• Daily instrument support
• Planning, executing and documenting the PM/Cals on laboratory equipmnet released for use in a cGMP regulatory environment
• Accompanying vendors (as requried) to ensure all documenation generated as part routine calibration/requalification is completed in a complant manner
• Review and approval of PM/Cal validaton documentaiton or reports
• Generation and resolution of protocol deviations and descrepancies as required
• Acting as primary contact for Lab Support for INFOR CMMS
• Working closely with user groups to evaluate, develop, implement and maintain laboratory equipment and software
• Maintaining laboratory equipment in accordance with CGMPs, Part 11 and other regulatory requirements
• Administration of lab software and CDS
• Conducting User access reviews on laboratory operting software
• Conducting Periodic review on laboratory operting software