Sr Associate - Controlled Document Management

Sr Associate - Controlled Document Management

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

This position has responsibility for the maintenance of the Document Management program across multiple disciplines within the R&D organization including but not limited to the coordination of documentation systems to ensure compliance, control, accountability, traceability, communication, retrieval and archiving of critical documentation throughout the lifecycle of the documents, including routing and issuance, and to provide timely customer service to all departments. This position will also act as a liaison between IT and the business for software and related process & continuous improvement projects.

Maintain and control the Document Management System (EDMS), i.e. QUMAS, to meet regulatory compliance.

Prepare and review SOPs and Process Deviations and 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.

Maintain and coordinate activities related to the document system including generating, revision, retiring the requirements and operational procedures for internal and external documents.

Provide expertise and input to other functional areas affecting controlled documents.

Generate and publish metrics and reports related to the quality system.

Maintain history files of SOPs, Forms and other controlled documents in strict compliance to departmental policies, regulations and standards.

Ensure controlled documents are periodically reviewed for compliance.

Assist in the preparation and coordination with requests from regulatory authorities and other compliance inspections / audits.

Independently manage a diverse array of projects and tasks with a collaborative style.

Education

B.S. degree required, science degree preferred

Experience

Minimum five (5) years' experience in the pharmaceutical industry

Experience managing electronic document repositories

Experience writing and creating standards for document management

Knowledgeable in FDA expectations is essential, demonstrated experience reading and interpreting regulatory documents

Direct experience in GXP compliant quality systems is preferred

Experience using QMAS or similar EDMS

Skills

Attention to detail

Excellent communication skills including: PC skills and good questioning and analysis techniques desired.

Must work effectively in a team environment and with individuals at all levels within an organization. Additional necessary characteristics include: being a self-starter, goal oriented, and ability to multi-task.

Careers Integrated Resources Inc