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QC Analyst, Analytical

Newark, CA

 

QC Analyst, Analytical | Onsite | Annual Bonus

Job Summary:

The Analyst in Analytical Quality Control ensures integrity and quality of drug substances and products by performing testing of raw materials, in-process samples, and finished goods using advanced laboratory techniques (e.g., ELISA, SDS-PAGE, Western Blot, HPLC). This role is responsible for accurate documentation of results, investigation of out-of-specification findings, equipment maintenance, and strict adherence to cGMP standards.  We are looking for a quality control analyst with extensive HPLC (preferably with biologics) experience to support our current portfolio and pipeline.

  • Reporting to:    Manager, QC Analytical
  • Location:          Newark, CA - On-Site 
  • Salary Range:  $77k - $97k annually + 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:

  • Testing & Analysis: Performing and reviewing of chemical/bioanalytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance and drug products for release and stability programs.
  • Data Integrity: Accurately record, analyze, and report results, identifying any deviations from specifications and procedures.
  • Documentation: Write/review SOPs, protocols, assay worksheets, stability reports, and quality records such as laboratory investigations, deviations, CAPAs, and change controls.
  • Compliance: Ensure the laboratory is in cGMP compliance with regulations (e.g., FDA and CDC), pharmacopeia standards, and established procedures.
  • Equipment: Maintain laboratory space to regulatory expectations and internal procedures regularly, including support of equipment qualification and onsite vendor support.
  • Troubleshooting: Conduct root cause analysis for quality issues and collaborate with cross-functional teams for resolutions.
  • Inventory: Manage lab supplies and samples
  • Safety and Training: Ensure a safe and secure laboratory environment, providing training to junior analysts on laboratory procedures and assays.
  • Collaboration: Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development, to resolve quality issues and support process improvements.

Basic Qualifications:

  • Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
  • 4+ years of regulated pharmaceutical industry experience
  • Must have experience with a range of biological and physicochemical methods.
  • Must have experience in peer-reviewing of Quality Control data.
  • Must have experience with a wide range of HPLC methodologies (CEX, SEC, RP-HPLC).
  • Experience with HPLC for peptides is a plus.

Preferred Qualifications:

  • Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
  • Effective written and verbal communication skills
  • Experience with a range of biological and physicochemical methods (pH, ELISA, Western Blot, SDS-PAGE, HPLC)
  • Proficient understanding of data integrity and ALCO+ principles
  • Experience supporting analytical instrumentation calibrations (work orders, reports, etc.) with vendors a plus.

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 PTO (12 days' 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.

 

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