Quality Assurance Specialist II

Job Summary:

The Quality Assurance Specialist II is an intermediate level position with Hands-on QA experience. Under 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 role will be interacting with cross-functional groups such as Quality Control, Manufacturing, MSAT, Facilities, Supply Chain, and Regulatory Affairs.

Reporting to: Sr. Manager, Quality Assurance
Location: Newark, CA
Salary range: $77,000 - 90,000 + annual performance 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.
• Coordinate and perform area approvals and product inspection.
• Review documents such as standard operating procedures, master batch records, and packaging and labeling records.
• Review executed production batch records and associated documentation, including any deviations related to batch disposition, for internal manufacturing and external CMO.
• Perform retain sampling and maintain reserve sample program.
• Act as a compliance resource to provide guidance and assistance towards resolution of issues under guidance.
• Perform review and disposition of incoming raw materials.
• Continuously improve quality operation processes; author/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.

Basic Qualifications:

• Bachelor's degree & 2+ years' directly related experience.

Preferred Qualifications:

• Bachelor's degree in biology, chemistry, or related science.
• 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.
• Good attention to detail.
• Ability to organize and multi-task in a fast-paced environment.
• Good working knowledge of cGMP standards applicable to commercial biologics.
• Prior experience with regulatory inspections and Veeva.
• Specific vision abilities required by this job may include passing a vision test in order to perform statistical inspections of drug product.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. 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 PTO, 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.