Job Summary:The
Sr. Specialist, Quality Assurance is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working in the Quality Systems team for providing quality oversight of the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. The individual will also provide support in maintaining the company's Data Integrity Program. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.
- Location: Newark, CA - hybrid schedule (3 days in office)
- Reporting to: Sr. Manager, Quality Assurance
- Salary Range: $105,000-$125,000 + annual bonus potential
- * the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.
Key Responsibilities:- Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products.
- Coordinate and track closure of quality records such as change controls, deviations, CAPAs, quality investigations, etc.
- Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation/Assurance(CSV/CSA) and applies risk-based methodology to validation/qualification efforts in accordance with current regulatory requirements and industry guidance.
- Provide quality oversight of the Information & Technology (IT) Department.
- Provides quality oversight of steady state activities (System Audit Trail Reviews, User Account Maintenance, Periodic Reviews) and quality records (deviations, CAPAs, and changes controls) for GxP Facilities, Utilities, Equipment, Analytical
- Instruments, and Computerized Systems.
- Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and reliability across the data lifecycle for GxP Operations.
- Support the development, collection, and management of quality metrics to optimize performance, productivity, and effective resource planning.
- Support continuous improvement of quality systems by authoring new or revising existing department procedures and/or forms.
- Assist in internal compliance audits as needed.
- Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
Required QualificationsEducation:- BS or equivalent in biology, chemistry or related science or equivalent experience
Experience:- Minimum of 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 of those years in QA or closely related field
- Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
- Good interpersonal and verbal and written communication skills
- Experience in aseptic processes is highly desirable and knowledge of biologics is a plus
- Ability to manage multiple clinical projects
- Good working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/drugs produced for clinical trial investigation
- Attention to detail with an ability to perform critical review of various types of technical documents
- Proficient with commonly used word processing, database systems and other software
What Revance invests in you:- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO (12 days' PTO), holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
