Quality Document Writer - Katalyst Healthcares & Life Sciences
Branchburg, NJ 08853
About the Job
Responsibilities:
- Day to Day: 10% or so editing change controls, 10% to 15% writing change controls, 50% + of the job working with multiple stakeholders.
- Cross functional teams to ensure all parts of the document are approved on multiple projects .(this is the project management experience the manager is looking for)
- Responsible for the development, creation, and revision of controlled documentation.
- Accordance with Client policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards.
- Establishes partnerships and works with Change Control, Quality Engineer team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information per process/product specifications.
- Must have previous experience with change control.
- Previous experience in pharmaceutical, medical device, or biotech industries.
- Software: Veeva One Vault (Quality Docs) OR Track wise.
- Strong Communication both written and verbal THIS IS VERY IMPORTANT.
Source : Katalyst Healthcares & Life Sciences
