Quality Assurance Specialist II

Job Summary:

The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working primarily on quality operations within the Product Quality Assurance group to support external CMOs on customized product and finished drug product operations. This individual will also work on quality events, product complaints, and support other quality activities for internal manufacturing operations. The individual will be interacting with cross-functional groups such as Materials Management, Quality Control, MSAT, and Manufacturing departments.

Reporting to:    Manager, Product Quality Assurance

Location:    Newark, CA - onsite

Salary Range:    $77,500 - $97,000

Responsibilities/Essential Duties:

• Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures and applicable US and international regulatory requirements for finished drug product distribution.
• Review executed production batch records and associated documentation for external operations of customized product and finished drug product.
• Review deviations, change controls, and CAPAs under supervision.
• Author new or revise existing procedures and/or forms to support continuous improvement of quality operations.
• Support investigations and closures of product complaints.
• Support preparation of quality system metrics.
• Support quality activities for internal manufacturing operations including area approvals, inspections, and other assignments.
• Assist with inspection preparation for regulatory agency inspection or third-party audits, as needed.
• Act as a compliance resource to provide guidance and assistance towards resolution of deviations, investigations, CAPAs, and change controls.

Basic Qualifications:

• Bachelor’s degree & 2 years’ directly related experience.
  

Preferred Qualifications:

• Bachelor’s degree in biology, chemistry, or related science and minimum 3 years’ experience performing quality assurance functions in pharmaceutical and/or biotech related fields.
• Experience in aseptic manufacturing processes.
• Knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• Proficient with commonly used word processing, database systems and other software.
• Ability to work with all levels cross-functionally.
• 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 interpersonal, verbal, and written communication skills.
• Specific vision abilities required by this job may include passing a vision test in order to perform statistical inspections of drug product.
• Good attention to detail.

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
• Flexible unlimited PTO, holidays, and 12 weeks' parental leave
• Generous healthcare benefits, Employer HSA contribution, 401k match, tuition reimbursement, 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.”

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.