GCLP documentalist in Raritan, NJ

As a GCLP documentalist, the candidate will support laboratory instrument qualification and change control, qualifying Excel tools, filing change control documentation, writing qualification reports, writing SOPs, supporting SOP development, maintaining laboratory inventory records (including chemical inventories, MSDS files and waste disposal) and working with archiving personnel.

The candidate will be responsible for understanding and applying QA systems and requirements to maintain GCLP-compliant processes within a Clinical Assays Laboratory environment, coordinating efforts with QA personnel.

Responsibilities will include instrument and procedural validations in support of GCLP activities.

He/she will provide guidance and assist in preparations for internal, external and regulatory audits and will draft associated audit and CAPA responses and reports.

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The candidate must demonstrate excellent scientific writing skills and must have experience working in a GCP laboratory, with detailed understanding of GCLP or GLP.

Familiarity with, and the skills to serve as a Subject Matter Expert for electronic quality systems and LIMS programs are important.

Successful candidates will have strong computer skills and be proficient in Microsoft Word, PowerPoint, Excel and Access.

The successful candidate will be goal oriented, have highly developed organizational skills and the ability to meet tight deadlines, be capable of multiplexing diverse tasks and be able to work effectively in a team environment.

The position requires a BA/BS/MS in a life science.

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