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.

• 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

IT REHAB CLINICAL NURSING

Inc. 5000 – 2007-2014 (8th Year)

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

Tel: 732-549-2030 x208

Fax: 732-549-5549

Direct: 732-549-5302

www.irionline.com

https://www.linkedin.com/in/rkavita