Quality Assurance Specialist III

Revance Therapeutics • Newark, CA

219d • $90,000 - $120,000

About The Position

The Quality Assurance Specialist III is an intermediate level position. Under moderate supervision, the individual will contribute to the development, implementation, and maintenance of the Quality Management System, including Deviation, Corrective and Preventative Action (CAPA), and Change Control Programs. This role will interact with cross-functional GxP groups such as Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.

Requirements

• Master's degree & 2 years of directly related experience; OR Bachelor's degree & 4 years of directly related experience; OR Associate's degree & 6 years of directly related experience.

Nice To Haves

• 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.
• Working knowledge of quality systems cGMP standards applicable to biologics drug substance and drug product.
• 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.

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.

Benefits

• Competitive Compensation including generous base salary and annual performance bonus
• Flexible unlimited PTO, holidays, and 12 weeks parental leave
• Generous healthcare benefits, Employer HSA contribution, 401k match, wellness discounts and much more

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree