CofA Clerk

Job description

Details:
What is the role purpose?

The Quality Systems department supports the maintenance of our site Laboratory Information Management System (LIFT LabVantage / Sapphire) and the creation and distribution of Certificates of Analysis (CofA), required to enable batch release to markets.
Quality Systems work in conjunction with teams across site and with customers both internal and external to enable recording / reporting of analytical data within LIMS and the reporting of result data via CofA enabling batch release in market.

How can I add value?

- Create / Check and Distribute Certificate of Analysis (CofA) and other batch release documentation in support of the batch release process.
- Provide customer support for the Certificate of Analysis process.
- Maintain documentation to support the CofA creation and distribution process & the LIMS in a compliant manner.
- Provide Customer support for CofA.
- Lead or support investigations involving CofA.
- Contribute to the preparation of facilities for all Quality and EHS Inspections. May lead or contribute to self-inspections.

Please note that this is 18 months FTC.

If requiring an adjustment for a disability, once selected for interview you may contact

Closing date for applications: 23rd March 2017

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Highly developed Microsoft office skills (Word/Excel/Access)
• Understanding of the requirements and application of GxP principles when working with IT systems

Preferred qualifications:
• Understanding of the Certificate of Analysis (CofA) process
• Understanding of the structure and operation of local Laboratory Information Management Systems (LIMS) (e.g. LIFT) and Resource Management Systems (e.g. SAP)
• Understanding of the data reporting requirements within and from LIMS and Resource Management Systems (e.g. SAP)
• Ability to source and interpret regulatory information and translate the requirements into LIMS and CofA
• Have good interpersonal skills, good influencing and networking ability