A Document Control or Management Specialist manages written and electronic documents for an office or company. Develops or maintains systems for keeping track of documents, including labeling, retrieving, distributing, recovering and destroying documents as needed.
Lead a team in the Document Control Department of up to 4 staff to prepare, update, review, and streamline the documentation process in quality, production, and other document-related areas. Provide documentation support in Production ensuring all documentations including but not limited to batch records, specifications, and SOP training records are filed in a timely and compliant manner. Complete, review, update, and approve SOPs and other control documents. Coordinate and provide new and updated SOP training. Participate in quarterly Quality Internal Audit and other
FDA, NSF
regulatory and vendor audits. Conduct Document related CAPA, NC, and Procedure Deviation investigations. Learn and follow all company guidelines and policies and ensure all documentation is filled out correctly and completely. Be able to troubleshoot and identify ways to improve and ensure production of Department and quality standards are met on a daily basis.
Required Skills:
Oral and written communication skills Able to work independently and in a team setting Attention to detail Oversee documentation activities in Production and Quality. Review and approve MBR/batch records for product compliance. Create, review, update, and approve SOPs and control documents. Coordinate and conduct SOP training sessions. Support Production to ensure efficient paper flow. Participate in Quality Internal Audits and regulatory/vendor audits (e.g., FDA, NSF). Conduct investigations for CAPA, NC, and procedure deviations. Attend daily production MRB meetings. Demonstrate strong oral and written communication skills. Manage rework, deviation, and change control documentation. Work independently and as part of a team. Support operations in Quality-related functions. Comply with FDA, cGMP/cGDP, and other regulatory requirements. Perform additional duties as assigned by the Quality Manager. Proficient in speaking, reading, and writing English.
Experience:
2+ years of Document Control Experience 2+ years of cGMP/cGDP Experience in
Quality Control/Quality Assurance Education:
High School Diploma or equivalent required BS/BA/College degree preferred
Pay:
From $16.38 per hour
Benefits:
401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Retirement plan Vision insurance
