Neurocrine Biosciences is seeking to provide quality assurance support for their electronic document management system (EDMS), quality management system (QMS), and learning management system (LMS). The role will assist in the day-to-day operations of these electronic systems, ensuring compliance with company policies, ICH, FDA, EU requirements, cGMP, and other applicable regulations.
Requirements
- Familiarity with regulatory documents is required
- Developing knowledge of FDA regulations and GxP guidelines
- Strong computer skills
Responsibilities
- Assists with user account management and basic security settings
- Helps respond to routine eSystem customer inquiries
- Assists in generating reports and dashboards for QADC and QMS analytics
- Supports data entry and file reconciliation activities
- Assists in system documentation maintenance
- Participates in routine quality assurance activities
- Supports inspection readiness activities
Other
- BS/BA degree in Chemistry, Biology, or related field and 2+ years of relevant experience OR Master’s degree in Chemistry, Biology, or related field and some similar experience as noted above
- Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers
- Comfortable with tools and processes that support work conducted by functional area
- Ability to work as part of a team
- Good problem-solving and analytical thinking skills
- Detail oriented
- Ability to meet deadlines
- Strong verbal and written communication skills are required
