Sr Documentation Specialist (Branchburg, NJ)
Role: Sr Documentation Specialist
Duration: 6 months (possible extentions)
Location: Branchburg, NJ
As a member of the Quality Systems Document Management team the candidate will:
- Collaborate with Design Transfer team associated with product launch, and Change Management teams to implement Master Documents in the Electronic Documentation Management System (EDMS) according to approved procedures, templates and standards, such as routing, tracking of document status, approval notification, version control, format conversion, metadata maintenance, distribution, and archiving.
- The candidate will be responsible to maintain document templates, project tracking logs, and databases through standard electronic formats.
- Assist Department members in managing Device Master Record Listings/Indices and EDMS permission/access.
- Assist with preparation of training materials and presentations.
- Participate in User Acceptance Testing and generation of requirements relative to electronic system releases related to EDMS or other electronic tool in use by the Documentation department.
- Under general supervision, the candidate will assist with the writing and revision of Standard Operating Procedures (SOPs), and/or documenting procedures for intra-departmental use and in accordance with applicable Quality and Regulatory requirements.
- Participate on Project Teams as a representative of Document Management.
- The candidate must possess strong MS Word and Excel skills.
- Experience working within an Electronic Document Management System and MS Visio is recommended.
- The candidate should be detail oriented and project/customer focused.
- The candidate must be able to handle multiple priorities and thrive in a fast paced, quality driven organization.
- The candidate must have a working knowledge of Quality Management Systems and applicable Regulations in the Medical Device or Pharmaceutical industries.
- 2 to 6 years in the diagnostics or pharmaceutical industry focusing on quality systems procedures, regulatory affairs/compliance, project management, controlled documentation, or change control.
Sthree US is acting as an Employment Business in relation to this vacancy.