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 mannerReview 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 softwareMaintaining 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 You will need to have: Working knowledge QC Lab systems and equipmentIn depth knowledge and understanding of current regulatory requirements for cGMP laboratory equipment The duties of this role are generally conducted in an lab environment.
As is typical of a labbased role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: A minimum of 5 years experience in a similar role A degree in chemistry, software or an engineering related disciplineExcellent technical competancy in relation to instrumentation and equipment validation Skilled in organising, planning and priority setting along with strong time management skills Works very well in a collaborative manner Takes a structured, analytical approach to problem solving. #LIGO1
$ads={1}
$ads={2}
