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