A phase 1/2a biosciences organization is looking to bring on a Document Control Specialist to join their team. You are going to be interacting with many teams cross-functionally specifically supporting the Quality Assurance team. Overall, you will be responsible for maintaining and establishing both paper based and electronic GxP records.
Responsibilities:
- Lifecycle document control management
- Work with the team to establish and maintain electronic document management system
- Create document control procedures and maintain standards associated with regulatory requirements (GxP, etc.)
- Support the clinical teams specifically in the creation of clinical SOPs, SOP review schedule , review the documents, etc.
- Maintenance of the database
Qualifications:
- At least 2 years within biotech/pharma space
- Knowledge of document control and regulatory compliance
- Experience in the use of Electronic Document Management Systems
- Strong communication skills
- Working knowledge of FDA/ICH regulations
- At least 3-5 years total experience . Pay to commensurate.
Benefits
- Health Benefits (Dental, Vision, Medical)
- 401K
- Paid sick days
If interested, please don't hesitate to apply as you will be reached out to as soon as possible!
