Quality Assurance Specialist
| Company | Revance |
|---|---|
| Location | Newark, CA, USA |
| Salary | $90000 – $120000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, Associate’s |
| Experience Level | Mid Level, Senior |
Requirements
- Master’s degree & 2 years of directly related experience; OR
- Bachelor’s degree & 4 years of directly related experience; OR
- Associates degree & 6 years of directly related experience
- Working knowledge of quality systems cGMP standards applicable to biologics DS and DP.
Responsibilities
- Perform a wide variety of Quality Assurance activities to ensure compliance with Revance procedures and applicable US and international regulatory requirements for biologic drug substances and drug products.
- Contribute to the development, implementation, and maintenance of Deviation, CAPA, and Change Control programs.
- Provide quality oversight of GxP Quality Events including deviations, CAPAs, change controls, lab investigations, and complaints.
- In collaboration with cross-functional GxP groups, coordinate and track the timely closure of Quality Events.
- Support Business Owner responsibilities for the use and management of Veeva electronic Quality Management System.
- Participate in the Change Control Review Board with cross-functional GxP Leads in the review and endorsement of GxP changes.
- Support the development, collection, and management of quality metrics and key performance indicators to optimize performance, productivity, and effective resource planning.
- Support continuous improvement of quality systems by authoring new or revising existing department procedures and forms.
- Assist in internal compliance audits as needed.
- Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
- Other duties as assigned.
Preferred Qualifications
- Bachelor’s degree or equivalent in biology, chemistry or related science or equivalent experience.
- Minimum 5 years of GMP experience in pharmaceutical and/or biotech related fields.
- Ability to independently analyze and reconcile simple issues.
- Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with commonly used word processing, database systems, and other software.