REMOTE QA Systems Specialist

Proclinical is currently recruiting for a REMOTE QA Systems Specialist with a pharmaceutical company located in Boston, MA. The QA Systems Consultant will support the quality systems needs of multiple large- scale projects as well as day to day customer support. This will require the ability to work cross functionally across the organization delivering exceptional customer support for electronic quality records administration for QMS processes such as Deviations, CAPAs and Change Controls in the eQMS Veeva System. This role will report to the Quality Systems Specialist.

Job Responsibilities:

• Complete eQMS training requirements to gain appropriate system access.
• Manage the QMS Support Inbox and provide assistance addressing requests as needed.
• Gather key process indicators data for monthly metric reporting of quality systems
• Support creation of eQMS reports and dashboards to demonstrate control of the process
• Provide guidance and training to users on CAPA, Deviations and Change Control Systems.
• Prepare and facilitate quality records meetings with record owners to track progress and
  maintain adherence to cycle times
• Support in the revision of process documents, including Standard Operating Procedures (SOPs),Work Instructions, Forms in accordance with company procedures and applicable global regulations.
• Attend and support cross-functional project teams as needed in representation of quality
• Other duties as assigned by Quality Management

Skills and Requirements:

• Previous Quality Assurance, QMS and/or controlled Quality Documentation experience preferred.
• Bachelor's Degree (BA/BS) preferred with 1 -2 years' experience in an FDA
  regulated environment or commensurate experience understanding of GMP/GDP
• Requirements for Quality Systems including Root
  cause analysis, investigation writing and corrective actions
• Strong MS Excel, MS Word and MS Powerpoint skills - Veeva or Trackwise experience preferred.
• Strong written and oral communication skills.
• Ability to multi-task and work in a fast-paced environment
• Ability to work with cross-functional teams.

If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at 484-840-5183. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-KH1