Documentation is critically important in biomanufacturing. Well-defined production Standard Operating Procedure documents enable consistent manufacture of the product as intended.
Education & Training:
This position is likely to require an Associates if working in food or other industries and a Bachelors degree or an Associates degree with experience if working in a company that makes drugs.
Common requirements and abilities:
- Project management skills
- Strong communication and customer service skills.
- Strong computer skills with MS Office
- Good organizational skills
- Some labeling experience strongly preferred
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
Documentation is critically important in biomanufacturing. Well-defined production Standard Operating Procedure documents enable consistent manufacture of the product as intended. Documentation not only helps make sure tasks and duties are standardized and adequately understood by all - it also creates a record of all tasks, duties and activities performed at any given time. Routine data collection throughout the enterprise includes all procedure details, times and dates, plus persons involved. Biomanufacturing is a highly regulated industry that involves a lot of paper work.
A QA Documentation Coordinator must keep track of numerous forms, reports, records, and more documents created in the company. Production data collected may range from set-up parameters for equipment to in-process tests that make sure each step is completed properly. Deviations are examined carefully as they could impact the quality of the product. Recorded information must meet specifications and follow cGMP steps and limits.
Documentation Coordinators work on investigations, analyze data and help produce change control documents. They audit materials to review for correctness and make sure all documents are up to date and easily available to the proper personnel. They maintain master copies of documents and assist in storing documents by scanning and other methods for archiving materials.
Accuracy and attention to detail are important skills for someone who is considering this type of job. Documentation specialists commonly work in regulatory affairs or quality assurance department offices. They may work independently or in a team. A Documentation Coordinator usually works a standard 40-hour workweek.
Alternate job title: QA Documentation Specialist, Quality Assurance Technician, QA Document Review