Global GxP Document & Record Control Sr. Specialist
Company: Sarepta Therapeutics Inc.
Posted on: January 16, 2022
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
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
* 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
* 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
* Issue, track, reconcile and archive paper laboratory
* 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
* 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
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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