Job Description
Duties and Responsibilities:
- Review quality system documents for Good Documentation Practices.
- Work with document owners for obtaining information and documents.
- Maintain document control records upon completion, i.e. scanning, filing.
- Review submitted document change requests to ensure all work and processes comply with established cGMP and other related standards.
- Provide feedback and request corrections as needed.
- Assist in processing documentation changes in document control system: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives.
- Support Document Control department activities.
- May be required to perform additional administrative duties to support Quality organization i.e. retrieving, filing, organizing, and cataloging records.
Education and Experience:
- High School Diploma.
- 2 year degree required.
- 4 year Bachelor degree preferred.
Knowledge, Skills and Abilities:
- Requires one (1) year work experience in a business operation involving diversity of duties and increasing responsibility.
- Experience with personal computer software in a business environment, including word processing, database, spreadsheet and draw programs.
- Working knowledge of Microsoft Office preferred.
- Ability to learn new software relating to this position.
- Ability to review technical documents, verify for accuracy, and identify errors for correction.
- Excellent verbal, written and interpersonal skills.
- Ability to make sound decisions, multi-task and prioritize.
- Be proactive in problem solving and driving resolutions.
- Excellent organizational skills and attention to detail.
Additional Requirements:
- Experience with electronic documentation systems.
- Basic understanding of science and regulations.
- Routing documents.
- Managing shipment to 3rd party storage.
- Data entry.
- Managing work flow.
- Uploading documents.
- Have excel and word experience word.
- Detail oriented.
- Basic computer skills.
- Some admin experience is a plus.
- Digitalization of documents- scanning.
- Inventory of paper based documents.
- Mango or EDMS preferred.
- Team player.