QC Senior Specialist, Lab Support

Alexion Pharmaceuticals

Athlone, Co Westmeath
Permanent
Full-time

1 month ago

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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.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.

Alexion Pharmaceuticals

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