Quality Assurance Specialist III

Job Summary:

The Quality Assurance Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimum supervision, the individual will be working primarily in quality operations providing quality assurance support to CMC teams and in-house DS and DP production, testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, Facilities and Manufacturing departments.

Reporting to:     Manager, Quality Assurance

Location:     Newark, CA (100% onsite)

Salary Range:     $89,125 - $122,578

Responsibilities/Essential Duties:

• Performs 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 under clinical development and commercial manufacturing.
• Performs incoming quality attribute inspections; reviews and dispositions incoming raw materials (e.g. chemicals, packaging and labeling materials, components etc.).
• Reviews documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports.
• Reviews executed production batch records and associated documentation including any deviation and investigation reports related to lot release, for internal or external operations.
• Performs retain sampling and supports the reserve sample program.
• Performs area approval, line clearance and product inspection.
• Performs product complaints investigations.
• Actively updates department databases to ensure up-to-date reporting of metrics.
• Supports continuous improvement of quality operations and department databases; authors new, revises existing and may review department procedures and/or forms.
• Supports quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs).
• Assists with inspection preparation and inspection strategy room for regulatory agency inspection or third-party audits.
• Acts as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; reviews and may approve quality system documents related to manufactured products.
• Assists in data verification of DS and DP sections of regulatory submissions as needed.
• Assists in internal compliance audits as needed.

Basic Qualifications:

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

Preferred Qualifications:

• Bachelor’s of Science or equivalent in biology, chemistry or related science.
• Minimum 4 years’ experience in the pharmaceutical or biotechnology industry, with at least 4 years’ working in operations or performing quality functions; experience in aseptic manufacturing processes.
• Ability to work with all levels cross-functionally.
• Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents. 
• Excellent interpersonal, verbal and written communication skills.
• Good working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP.
• Works independently with minimum supervision to accomplish goals.
• Relies on extensive experience and judgment to resolve simple to moderately complex issues.
• Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments.
• Prior experience with regulatory inspections is desired.
• Specific vision abilities required by this job include passing a vision test in order to perform statistical inspections of drug products.
• Multi-tasking and attention to detail.
  

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 annual 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.