The posting
Job Summary:
The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience. Under supervision, the individual will be working on the Product Quality Assurance team to support drug product packaging and labeling operations, and product disposition in compliance with cGMP and regulatory guidelines. This individual will also work on quality events, product complaints, and support other quality activities, as required. The individual will be interacting with cross-functional groups such as Supply Chain, Quality Control, MSAT, and Manufacturing departments.
Reporting to: Manager, Quality Assurance Location: Newark, CA - hybrid Salary range: $78,000 – $97,000 + 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 and applicable US and international regulatory requirements for finished drug product distribution.
- Maintain, track, review, and investigate product complaints.
- Review executed production batch records and associated documentation for finished drug product and customized product.
- Review documentation for product release.
- Review deviations, change controls, and CAPAs under supervision.
- Maintain retain inventory of finished drug product.
- Author new or revise existing procedures and/or forms to support continuous improvement of quality operations.
- Support preparation and maintain quality system metrics.
- Support quality activities for internal manufacturing operations, including area approvals, inspections, and other assignments as needed.
- Assist with inspection preparation for regulatory agency inspection or third-party audits, as needed.
- Perform data verification for regulatory submission documents, as needed.
- Act as a compliance resource to provide guidance and assistance towards operations and resolution of deviations, investigations, CAPAs, and change controls.
Basic Qualifications:
- Bachelor’s degree & 2-5 years’ directly related experience.
Preferred Qualifications:
- 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.
- Strong 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.
- Strong attention to detail.
- Experience in aseptic manufacturing processes.
- Knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidelines documents.
- Experience with Veeva QMS.
- Proficient with commonly used word processing, database systems, and other software.
Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company’s vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance’s award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
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.
