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.

Careers Integrated Resources Inc