Position Summary
The Packaging Documentation & Records Administrator is responsible for the preparation, control, and administration of all packaging production records and associated documentation (i.e. label proofs). This role focuses on document generation, data accuracy, and record management, ensuring that all documentation is properly created, reviewed, tracked, and archived in compliance with company and regulatory standards. The position may also provide occasional hands-on support to packaging and labeling operations as needed.
Organizational Position
This post holder reports directly to the Operations Manager, or designee, but they will work closely with CalCog’s Client Services, Commercial, Operations, Quality, and Regulatory teams.
Roles & Responsibilities
- Generate and distribute packaging production records based on production schedules
- Generate, manage, and maintain label proof documents, ensuring accuracy of artwork, text, and version control prior to approval and use
- Maintain strict control over document versioning, formatting, and numbering systems for both production records and label proofs
- Ensure all required documentation is complete, accurate, and issued in accordance with established timelines
- Serve as the central point of contact for production record and label proof requests and updates
- Track the status of issued records and label proofs; follow up on outstanding approvals or incomplete documentation
- Perform administrative review of completed records and approved label proofs for completeness and proper sign-offs
- Log, file, scan, and archive records and label proof documentation in both the data storage room and SharePoint
- Support document retrieval for audits, inspections, and internal reviews
- Coordinate document and label revisions with Quality Assurance, Regulatory, and other departments
- Provide occasional support to packaging and labeling activities, including assisting with product verification, staging, charge-in, and actual labeling
- Meet established timelines and SLAs for completion of all activities.
- In accordance with policy and confidentiality disclosure safeguards, protect the safety and integrity of company and client information.
- Complete training, including SOPs and Work Instructions, within documented timeframes.
- Perform other duties as assigned, according to the changing needs of the business.
Qualifications
- High-School (US) education (or equivalent) as a minimum, Bachelor’s degree preferred
- 1–3 years of experience in an administrative, document control, or records management
- Familiarity with version control procedures
- Proficiency in Microsoft Office and document management systems
- Experience in a regulated environment (pharmaceutical, food, cosmetics, or manufacturing) is preferred but not required
Skills & Competencies
- Exceptional attention to detail and accuracy, especially in text and artwork review
- Strong organizational and records management skills
- Ability to manage high volumes of documentation and multiple version-controlled files
- Strong written communication skills
- Ability to work independently and meet deadlines
- Familiarity with document control and labeling compliance standards
- Flexibility to support operational tasks when required
- Demonstrates an above average level of manual dexterity.
Working Conditions
- Work is performed in a climate controlled, office/production/warehouse environment.
- Occasionally required to perform job duties in a walk-in refrigerator (36-46 degrees Fahrenheit).
- Personal protective equipment is required such as garments, hair nets, shoe covers and occasionally latex gloves (provided by CalCog).
Physical Requirements
- Ability to work in an upright and/or stationary position for up to 8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists.
- Light to moderate lifting and carrying (or otherwise movements) objects including packaged and unpackaged drug, packaging supplies and other cartons and/or containers as required, with a maximum lift of up to 30 pounds.