Sr. Quality Assurance Specialist

Job Summary:

The Sr. Specialist, Quality Assurance is an advanced-level position with hands-on QA experience. Under minimal supervision, the individual will be working in the Product Quality Assurance team, primarily providing quality oversight and support to internal and external drug substance and drug product production and lot disposition. This individual will also provide quality support to Quality Control and Facilities. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, MSAT, Facilities, Supply Chain, and Regulatory Affairs.  

• Reporting to:  Manager, Quality Assurance
• Location:  Newark, CA, Onsite
• Salary Range: $105k - 130k + Bonus 

* 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. 

Responsibilities & Essential Duties:

• 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. 
• Review documents such as standard operating procedures, master batch records, packaging and labeling records, test methods, qualification protocols, and reports 
• Review executed production batch records and associated documentation, including any deviation and investigation reports related to batch disposition, for internal manufacturing and external CMO 
• Review and approve quality records in a timely manner 
• Act as a compliance resource to provide guidance and assistance towards resolution of deviations, lab investigations, excursions, quality investigations, OOTs, work orders, change controls, and CAPAs 
• Perform area approvals and product inspection 
• Support review and disposition of incoming raw materials 
• Support management of the reserve sample program 
• Continuously improve quality operation processes; author new and review/revise existing procedures and forms 
• Assist in data verification for regulatory submissions 
• Assist with inspection preparation/strategy in internal compliance audits, regulatory agency inspections, or third-party audits 
• Update department databases to ensure accurate reporting of quarterly metrics 

Knowledge, Skills, and Abilities 

• Excellent interpersonal, verbal, and written communication skills 
• Uses experience, knowledge, and judgement to resolve simple to complex issues 
• Works independently with minimum supervision to accomplish goals and timelines 
• Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments 
• Good working knowledge of cGMP standards applicable to commercial biologics 
• Specific vision abilities required by this job include passing a visual acuity test 
• Prior experience with regulatory inspections and Veeva is desired 

Basic Qualifications: 

• Bachelor’s degree in relevant field 
• 6+ years experience  
• Good working knowledge of cGMP standards applicable to commercial biologics 
• Specific vision abilities required by this job include passing a visual acuity test 
• Prior experience with regulatory inspections and Veeva is desired 

Preferred Qualifications:

• Prior experience with regulatory inspections and Veeva is desired 
• Experience with aseptic fill/finish 

Company Summary:

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus.
• Generous Paid Time Off, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.