Quality Control Associate, Stability

Job Summary:

The QC Associate, Stability is part of the analytical team, and  will be responsible for coordinating the stability program within the QC department. This role ensures that stability studies are conducted in compliance with regulatory requirements and company standards. The QC Associate will also handle sample management tasks, including receiving, logging, storing, and distributing samples. Stability studies will be managed for Drug Substance, Drug Product, Peptide and Primary Reference Standards. This role will also author and revise SOPs, stability protocols and reports, stability amendments, and any other related Quality documents.

Reporting to:     Stability Supervisor

Location:     Newark, CA (5 days/week onsite)

Salary Range:     $63,825 - $84,249

Responsibilities/Essential Duties:

• Coordinate stability studies, including sample pulls, testing schedules, data collection, and stability summaries.
• Maintain stability chambers and ensure they are operating within specified conditions.
• Document and track stability study data, ensuring accuracy and compliance with regulatory requirements.
• Author stability protocols, reports and stability amendments for regulatory submissions and internal reviews.
• Receive, log and store incoming samples (in-process, release, stability, R&D and raw material) according to established procedures.
• Manage sample inventory, ensuring accurate tracking and availability of samples.
• Participate in internal and external audits and inspections as required for stability program and sample management.
• Identify and report any deviations or non-conformities in stability studies or sample management processes.

Basic Qualifications:

• Bachelor’s degree; OR
• Associate’s degree & 4 years’ directly related experience

Preferred Qualifications:

• Bachelor’s degree in Chemistry, Biology, or a related field.
• 1-2 years' experience in a QC laboratory, preferably in stability and sample management.
• Knowledge of GLP, GMP, and regulatory requirements related to stability studies and sample management.
• Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity; solutions oriented and able to problem-solve and identify root cause.
  

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.