Document Control Coordinator

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

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.