Document Control Coordinator

3 days ago

WinstonSalem North Carolina United States Solesis Full time

Who we are:

Charter Medical, LLC is a life sciences company that is committed to designing, developing, and manufacturing quality products to support cell and gene therapy, bioprocessing, and blood management. 

About the role:

The Document Control Coordinator ensures the effectiveness of the document management system and training program, in support of FDA 21 CFR Parts 210, 211, 820 and ISO 13485:2016. The Coordinator works with the Management Team to assure compliance to customer requirements, external standards, and internal specifications/procedures.

1st Shift:  Monday - Friday 7:00am-3:00pm 

What you will do:

  • Assists in the implementation and maintenance of the Quality Management System (QMS) documentation  while ensuring compliance with applicable standards, regulatory,  customer requirements and overall protection of company intellectual property.
  • Assures the Document Change Control Request process is performing as stated in the applicable Work Instruction (WI).
  • Reviews, and routes  controlled documents  including System Procedures (SPs), Standard Operating Procedures (SOPs), Work Instructions (WIs), and Internal Specifications  to ensure accuracy and revision control.  
  • Maintains controlled documents.
  • Maintains Change Control Request process to ensure compliance with applicable (WIs).
  • Assures control of quality records (including records retention) are compliant with  applicable WIs.
  • Verifies and confirms completion of assigned quality training as applicable.
  • Conducts new hire Quality Orientation Training.
  • Responsible for the review and accuracy of labels in BarTenderras the Administrator/Super User.
  • Assists in internal/external audits by supplying documents as applicable.
  • Supplies applicable Metric Data as requested.
  • Issues Customer Notification numbers and maintains customer notification log and files.
  • Maintains the Deviation Log and issues deviation numbers.
  • Maintains Memo log.
  • Maintains off-site storage of records, including requesting pickups, ordering boxes, etc.
  • Performs other activities and other projects as requested by RA/QA Management.
  • Act as a Quality ambassador for the company to promote Quality culture.

Who you are:

  • High school graduate or equivalent required. Associates Degree preferred.
  • 2 – 3 years of relevant experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 210, 211 and 820) in one of the following functions: Quality Control/Assurance or Document Control , preferred.
  • 1-2 years' experience developing or maintaining a controlled document system in a regulated industry required.
  • Intermediate or advanced level of knowledge of ComplianceWire, BarTender, MS Office Suite and Adobe projects (specifically Adobe Acrobat Pro).
  • Possess excellent communication, organizational and computer skills.
  • Must be able to work independently and set priorities in alignment with business needs.

Perks / Benefits:

  • Generous Paid Time Off
  • Paid Breaks
  • Annual Bonuses
  • 401k with excellent company match
  • Health Insurance with multiple plans to choose form
  • Paid Short Term and Long Term Disability

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