SQL Server DBA

The successful candidate will assure GLP compliance with applicable regulatory requirements including audits, training programs and documentation review.

Primary Duties and Responsibilities
Represents and interfaces with multiple departments and external providers to provide Good Laboratory Practices guidance in an effective manner.

Develops, revises, and reviews Standard Operating Procedures.

Performs internal GLP audits and or assists in the coordination of audits from outside parties.

Addresses, resolves and mediates corrective actions in audit findings and prepares written reports as necessary; ensures training of internal staff as appropriate.

Maintain QA CRO files.

Trouble-shoots and takes the initiative on any QA-related issue for GLP compliance.

Performs QA In-Study audits to ensures completeness and accuracy of information contained in all study documentation.

Maintains the GLP archives; and participates in the implementation and maintenance of the document management system.

Reviews protocols, study reports, and ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GLP guidelines.



Preferred Requirements
Bachelors (BS) in the Life Sciences or related discipline.

At least four to six years demonstrated experience in the GLP responsibilities listed above.

Strong knowledge of GLP regulations and good documentation practices.

Strong writing skills in protocols, SOPs and QA reports.

Must be authorized to work in the US without sponsorship. No third parties please.

Must have a pharmaceutical background.