Sr. Specialist, Quality Assurance

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. 

Reporting to:   Director, Quality Assurance

Location     Remote

Salary Range:     $102,465 - $140,921

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. 
• 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 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.
• Other duties as assigned. 

Basic Qualifications:

• Master’s degree & 2 years’ directly related experience; OR
• Bachelor’s degree & 4 years’ directly related experience; OR
• Associates degree & 8 years’ directly related experience

Preferred Qualifications:

• BA or equivalent in biology, chemistry or related science or equivalent experience. 
• Minimum 6 year’s GMP experience in pharmaceutical and/or biotech related fields. 
• Working knowledge of quality systems cGMP standards applicable to biologics DS and DP. 
• Works under moderate supervision. 
• 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.
• Good verbal and written communication and interpersonal skills.
• Proficient with commonly used word processing, database systems and other software. 

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It’s time to rethink everything you thought an employee experience could be.

What Revance invests in you:

• Competitive Compensation including base salary and target bonus
• Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leave
• Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more

Note: Revance has agreed to merge with Crown Laboratories.  Upon completion of this merger, benefits are subject to change.

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.”

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual’s race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.