QC Senior Specialist, Lab Support

2 weeks ago

Mississauga ON, Canada AstraZeneca GmbH Full time

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

You will need to have:

  • Working knowledge QC Lab systems and equipment
  • In 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 lab-based 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 non-linear 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 discipline
  • Excellent 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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