Senior Associate, Controlled Document Management

Senior Associate, Controlled Document Management

This position supports the Research and Development (R&D) organization and is responsible for assisting in the maintenance, management and retirement of controlled process documents, including the tracking of deviations related to such processes.

Job Responsibility:

• Ability to navigate and work within an electronic document management system (EDMS).
• Maintain and coordinate activities related to the EDMS including generating, revising and retiring R&D controlled process and operational documents.
• Maintain the metadata associated with the aforementioned R&D controlled documents.
• Ability to handle multiple assignments in a fast-paced environment with changing priorities.
• Process incoming documents according to established document control procedures.
• Maintain process related deviations in accordance with process requirements.
• Prepare and review SOPs to ensure the submitted documents meet R&D controlled document quality standards.
• Assure controlled documents are appropriately reviewed and approved prior to implementation via the change control process. Provide expertise and input to other functional areas related to R&D controlled documents.
• Assist in the generation of metrics and reports related to the R&D process document control.
• Support the periodic review of R&D controlled documents for compliance.
• Assist in the preparation and coordination of requests from regulatory authorities and other compliance inspections/audits.

Qualifications:

• B.S. degree required
• Minimum three (3) years' experience in a regulated industry
• Knowledgeable in FDA expectations is preferred
• Direct experience in GXP compliant quality systems is preferred
• Excellent document processing skills including: document quality review, typing and PC skills (MS Word, Excel, PowerPoint, Adobe Acrobat, etc.).
• Excellent communication skills including: customer service, ability to influence, negotiate, and conflict management skills.
• Must work effectively and independently in a team environment and with individuals at all levels within an organization.
• Additional necessary characteristics include: being a self-starter, goal oriented, attention to detail, and ability to multi-task.

With Regards,

Kavita Kumari

Clinical Recruiter

Integrated Resources, Inc

Inc. 5000 –  (8th Year)

Certified MBE I GSA
- Schedule 66 I GSA
- Schedule 621I I GSA
- Schedule 70