Quality Compliance Document Control Coordinator

Job Overview
We are seeking a proactive and detail-oriented Quality Compliance Document Control Coordinator to join our dynamic team. This position reports to the Quality Assurance Manager in the Quality Department. The purpose of this role is to ensure all documentation control systems are within GMP regulations to ensure the production of quality products. This position will own and maintain our current Document Control system while also helping in our transition to an eQMS in the near future. At that time, this role will help maintain the eQMS while still managing some paper based systems such as batch record issuance and review.

Duties

• Process SOPs, Forms, Logs, Raw Material, PKG Component & Finished Product Specifications, Analytical, Micro & Physical Test Methods and more to ensure the controlled copies are available for staff and that Master copies are maintained.
• Process change controls to ensure change are done in a timely manner and changes are processed correctly with all files placed in designated, organized areas for physical and electronic copies.
• Process and store QMS documents and ensure physical and electronic copies are stored and organized in a compliant manner.
• Batch Records issuance to production. Manage physical and electronic files for current and retired master documents; provide clerical support for document creation/modification.
• Site Training Files – update and manage training documentation system for all staff training and follow-up on overdue items. Manage physical and electronic training records, the electronic training matrix and ensure training plans are complete for each employee.
• Periodic Reviews for SOP/Forms/Specifications/Methods - organize and communicate when and what periodic review is due, lead efforts for effective periodic review, ensure timely review by department designees and follow up for timely completion.
• Document control area – maintain and manage all physical and electronic files into an organized, meaningful and traceable manner; make guides or keys for all pertinent employees to understand and access documents as needed
• Validation Documentation –manage physical and electronic files including master protocols, execution copies, executed protocols and final summary reports; ensure they are organized and logged in a meaningful and traceable way.
• Work with applicable departments to update and own batch records, batch record changes, batch record logs and all manufacturing records associated with any lots produced.
• Submit samples to testing facilities (in-house and outsourced)
• Testing Lab management - follow-up with results for raw materials and finished good monitoring for on time delivery.
• Help author SOPs, Forms, reports as needed, additional duties as assigned.

Qualifications

• High School Diploma or GED required. Associate degree preferred
• 1+ years’ experience with document control in a regulated industry, preferably in pharmaceuticals
• Excellent computer skills, including proficiency in Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint)
• Self-starter with excellent follow-through requiring little supervision

Join us to be part of a dedicated team committed to excellence in quality management! We value precision, organization, and proactive communication—key ingredients for ensuring our products meet the highest safety and quality standards worldwide.

Please Note: We are not accepting submissions from recruiters or staffing agencies. Visa sponsorship is not available for this position, and relocation assistance will not be provided. Candidates must be authorized to work in the United States.

Pay: $25.00 - $30.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person