Excellent opportunity for a Documentation Specialist with a leading Biopharma Company in Sligo on a 6 month contract. The Documentation Specialist will join the QC Group and will mainly support with batch records, managing lab test results and presenting them to the QP for batch release.
Overview of your responsibilities (full job description available on request)
Coordinate and manage the review, approval, and control of laboratory documentation.
Drive documents through approval workflows to meet timelines and cGMP requirements.
Serve as a key contact for laboratory documentation status and process updates.
Support document management within laboratory documentation systems.
Partner with cross‑functional teams during NPI, technology transfer, and routine manufacturing activities.
Ensure compliance with GMP, quality standards, and site procedures.
Monitor and analyse laboratory performance and process metrics.
Create, review, revise, and maintain SOPs, logbooks, forms, and other controlled documents.
Support the preparation of reports, presentations, and documentation updates.
Ensure laboratory documentation remains accurate, compliant, and inspection‑ready.
Knowledge, Skills and Experience Required for the Role
Bachelor’s degree in Science or a related field preferred.
1–3 years’ experience in a regulated laboratory or GMP environment.
Experience in document control and records management.
Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Visio.
Skilled in reviewing and editing controlled documents for cGMP compliance.
Experience with electronic document management systems is advantageous.
Proven ability to prepare, review, and approve GMP documentation to GDP standards.
For a confidential discussion and more information on the role contact Courtney Russell.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
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