Regulatory Windchill Coordinator in Maplewood, MN at Volt

Date Posted: 6/3/2019

Job Snapshot

Job Description

Volt has an opening for a Regulatory Windchill Coordinator in St. Paul MN.

Volt's Client is an American healthcare company that has a broad range of branded generic pharmaceuticals, medical devices, diagnostics, and nutrition products.

  • Create and update SAP - GTS licenses releases per the Product Release Authorization (PRA) process.
  • Initiate Additional Release Authorization (ARA) documentation when notified of a regulatory approval. Process ARA through WindChill document management system and update SAP - GTS licenses as appropriate.
  • Update and maintain documentation for release processes, department work instructions and guidance documents.
  • Responsible for maintaining and requesting CFGs and COEs. Provide FSC support when needed.
  • Create standard approval database reports weekly, monthly and as requested.
  • Provide admin legalization for regulatory database and SharePoint.
  • SharePoint administrator responsible for site updates and requests.
  • Integrate Excel files from various departmental personnel into consolidated reports with consistent formatting.
  • Prepare and process weekly, monthly, quarterly and year end departmental measurements. Create and maintain presentations for the measurements.
  • Plan and coordinate departmental meetings and special events and develop presentations for related on-site and off-site meetings.
  • Administration support for onboarding new employees and rotational specialists.
  • Support Regulatory Operations Specialists in day to day tasks.
  • Responsible for running reports and completing database updates.
  • Provide support on departmental special projects. Gathering and organizing data.
  • Take initiative to ensure work is done accurately and completely.
  • Organized and detailed orientated.

Skills Required:  Windchill, Documentation, Regulatory, SAP, Excel

Pay rate is up to $27 per hour depending on experience.

This position is Non-Exempt

Volt is an equal opportunity employer

Contact Recruiter at (602)889-0711