Documentation Control Specialist II chez None

Document Control Specialist II is responsible for the issuance and storage of controlled documents (batch Records, work instructions and product labels) to support production and release and shipment of products. These records once executed, reviewed and completed are stored per standard procedure for eventual retrieval to meet customer, regulatory or internal needs.   Works under general supervision.

Duties and Responsibilities: 

• Following standard procedures, issue-controlled copies of production records (batch records and work instructions) to production for execution and logbooks as requested.
• Following standard procedures, prepare original labels for review by secondary Quality Assurance personnel. Provide secondary review of prepared labels. Upon completion of secondary review, issue labels and supporting documentation to production and shipping.
• Communicate with the appropriate requestor the timeline and status of the completion of controlled document requests.
• Communicate to appropriate Quality Assurance staff if an issue is observed that has the potential to impact quality and work with the appropriate quality or production staff to resolve the issue
• Once a controlled document is executed, reviewed by Quality Assurance and confirmed to be complete, reconcile as appropriate the record with the issuance records
• Following standard procedures, scan and bind as appropriate the completed production records and place them into storage.
• Responsible for the "user level" organization and management for the physical and digital archive of controlled documents, including reconciliation of storage logs.
• Following standard procedures complete document disposition letters for submission to customer. Prepare hardcopy documents for disposal or transfer to customer.
• Maintain and update the Master Document List and controlled documents to ensure accuracy and compliance with CGMP requirements.
• Manage physical and electronic archives, including scanning, review, check-in/check-out, and secure disposal of documents.
• Perform data entry and trending in Excel or LIMS, creating charts and analyzing data to support quality and process improvements.
• Review production and QC document packets for completeness, accuracy, and readiness for filing.
• Organize and maintain document logs, spreadsheets, and status trackers to ensure accessibility and data integrity.
• Communicate timelines and status of requests, addressing issues and ensuring smooth document control operations.
• Perform additional duties as assigned to support overall document control functions.

EDUCATION AND EXPERIENCE

• Typically requires 1-3 years of related experience and a high school diploma or equivalent OR may have 0 years of experience plus an associate’s degree, or additional training, or certification.
• Associates degree preferred.

COMPETENCIES/SKILLS

• General computer skills
• Ability to use Microsoft Office applications
• Printer/Scanner operation

CERTIFICATIONS and LICENSES

• Not Applicable

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time