Sr. Associate

Sr. Associate

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.

Location:

Cambridge, MA Duration: 6 months + 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.

B.S. degree required, science degree preferred

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

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.

Ability to multi-task while effectively managing time and meeting critical deadlines

Flexibility and ability to plan, prioritize, and execute multiple tasks in a fast paced environment

Ability to work closely as a member of a team and independently

Have a strong customer focus

Good project management skills and/or substantial exposure to project-based work structures

Effective time management skills to meet deadlines

Must be self-motivated, well-organized, and detail oriented

Excellent written and oral communication skills.

Strong analytical skills

Excellent listening and interpersonal skills.