Job Description
Organon is recruiting for a Quality Administration Specialist to join our world-class manufacturing site in Cramlington, Northumberland. In this role, you will provide technical administrative support to the Production / Quality department in a number of key areas.
Role Responsibilities:
1. Generate, store, distribute and archive Certificates of Analysis (CoA), and related documentation to meet shipping / customer deadlines and to ensure accuracy and completeness.
2. Facilitate and maintain customer certification package electronic interface.
3. Primary contact to monitor and respond to the CoA email inbox for adhoc requests, fielding and escalating general enquiries.
4. Perform GMP review of Cramlington batch certificate / release package documentation and associated data as required.
5. Administrative functions to support Bulk IPT quality e.g. metric collation, scanning, filing and tracking of customer certification documentation queries and follow up of actions.
6. Organisation and maintenance of documentation storage areas.
7. Author, review and approval of SOPs / Job Instructions as required.
8. Drive and contribute to department continuous improvement using lean principles and identify potential changes.
Skills, Qualifications & Experiences:
1. Excellent communication skills and ability to work in cross-functional teams.
2. Experience working in a pharmaceutical environment.
3. Attention to detail and a well-organised approach to working.
4. Strong Continuous Improvement mindset with experience and skills in the tools.
5. Competent end user of desktop applications e.g. word, pdf, excel and access.
6. Support and sometimes lead projects within the team.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
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