Quality Assurance Documentation Associate

Job Title: Quality Assurance Documentation Associate
Pay Rate: Up to $33.03/hr DoE
Location: Westborough, MA
Zip Code: 01581

An Associate, Quality Assurance Documentation job opportunity is available with our client in Westborough, MA. In this role you will be responsible for Document Issuance Support: Assist with the issuance of GxP documentation utilizing the Veeva Document Management System. To be considered for this role you will have BA/BS or equivalent with typically 1+ years relevant experience or GED with relevant work experience.

Job Duties:
* Assist with the issuance of GxP documentation utilizing the Veeva Document Management System.
*Will assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and policies and procedures.
*Document Issuance Support: Assist with the issuance of GxP documentation utilizing the Veeva *Document Management System.
* Document Reconciliation Support: Assist with the reconciliation of returned GxP in the Veeva Document Management System and final disposition of reconciled documents.
* Document Control Support: Provide assistance with document control-related activities, including procedure creation and revision, as needed.
* Training Documentation Support: Provide assistance with creation of training folders and filing for associated training documentation in the Document Control room.
* Collaboration with Department Stakeholders: Assist with implementation of document change requests to ensure GxP documents are provided in a timely manner to stakeholders after creation or revision of a document.
* Documentation Discrepancy Resolution: Assist with investigating discrepancies related to missing or misplaced documentation.

Required Qualifications:

* BA/BS or equivalent with typically 1+ years relevant experience or typically 0 years with Masters degree.
* Familiarity with most major elements of job description, direct experience with at least one major area.
* Basic familiarity with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance and ICH Guidance.
* Proficiency with Microsoft Word formatting tools and techniques, to include manipulation of headers / footers, page control, document sections, orientation, styles, and editing markup / tracked changes.

Preferred Qualifications:
* Experience using document management software in a regulated industry.
* Proficiency in MS Excel, PowerPoint, and/or Visio to include creation / formatting of charts and data tables.

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com.

EOE/F/M/Disability/Veterans