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Global GxP Document & Record Control Sr. Specialist

Company: Sarepta Therapeutics Inc.
Location: Andover
Posted on: January 16, 2022

Job Description:

The Sarepta Therapeutics Quality Assurance Unit is seeking to fill a permanent full-time position for a Global GxP Document & Record Control Specialist, assuming responsibilities associated with managing controlled documentation and quality records in support of Sarepta's Global GxP Quality Management System.

The successful candidate will have experience working within in a regulated pharmaceutical/biotech environment and will be expected to interact with personnel across all levels and functional areas within the company. The position will encompass various tasks, including but not limited to, adequately controlling GxP documentation and quality records; ensuring all on-site/off-site quality records are safeguarded and retained across all Sarepta locations/affiliate sites; aiding to oversee Document Control Coordinator and Records Vault Owner Programs in accordance to Sarepta Policies and Procedures; maintaining metrics and monitoring the periodic review process; and other additional Document Control responsibilities as assigned.

This role will work closely with QA Compliance / Quality Systems personnel to ensure sustained compliance across Sarepta's QMS and GxP Document & Records Control System.

This position reports to the Sr. Manager, Documentation & Records Control.

Primary responsibilities include:

* Perform compliance reviews of draft documentation/document change controls as they are processed through Sarepta's electronic Document Management System.
* Develop, oversee, and execute document control procedures including the creation, routing, review, approval, distribution, periodic review and archiving of new and revised controlled documents.
* In conjunction with Training Staff, develop and provide Document Control compliance and system training, as well as training for other programs within scope of responsibility as a designated SME.
* Perform and support Document Control tasks within Sarepta's electronic GxP Document Management System, as assigned.
* Maintain inventory tracking logs and oversee issuance of controlled numbers utilized to support other GxP business processes.
* Issue, track, reconcile and archive paper laboratory notebooks.
* Co-manage the GMP archival vault located in Andover, MA and manage off-site records storage program.
* Assist in compiling quarterly KPI/metrics and performing trending analysis of the Document Control system to ensure compliance and drive continuous improvement activities.
* Provide inspection readiness support during internal audits and regulatory inspections.
* Complete cross functional training and backup support to Quality Systems team members.

Desired Education and Skills:

* BA/BS degree in a related field or equivalent experience.
* Minimum of 5 years' related work history, in a similar or advanced position within a regulated environment required; preferably reporting into a QA function.
* Experience administering an electronic Document Management Systems a must (Veeva Quality Docs a plus).
* Advanced proficiency in Microsoft Word, including editing, formatting, creating/utilizing templates, creating forms, embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required.
* Must be flexible, organized, detail-oriented, and able to handle multiple priorities in a fast-paced environment.
* Excellent oral/written communication, problem solving/issue resolution, and prioritization skills required.
* Ability to work independently and in team environments; understanding of GxP Quality Requirements and familiarity with Good Documentation Practices and ALCOA+ concepts.
* Experience training personnel on Document Control, Records Management and/or Quality Assurance concepts.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Keywords: Sarepta Therapeutics Inc., Boston , Global GxP Document & Record Control Sr. Specialist, Other , Andover, Massachusetts

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