Quality Control (QC) Manager (Pharma)

TL;DR

Quality Control (QC) Manager (Pharma): Overseeing and executing all QC shop floor activities to ensure compounded sterile preparations meet quality, safety, and regulatory standards with an accent on USP and FDA compliance. Focus on managing laboratory testing, conducting root-cause analyses, and implementing corrective and preventive actions (CAPA).

Location: On-site in Gilbert, Arizona

Company

A leading health and wellness platform redefining healthcare through affordable and personalized access to care.

What you will do

• Oversee sampling and testing of sterile drug products for potency, identity, and sterility.
• Coordinate with third-party laboratories and approve Certificates of Analysis (COAs).
• Manage shop floor QC activities and supervise environmental monitoring in ISO-classified areas.
• Conduct root-cause analyses and document event investigations to implement CAPA.
• Maintain accurate quality records and ensure data integrity according to ALCOA+ principles.
• Partner with leadership to support regulatory audits and pharmacy staff training.

Requirements

• Bachelor’s degree in Chemistry, Microbiology, Biology, or Pharmaceutical Sciences.
• 3–5 years of QC experience in sterile compounding, pharmaceutical, or biotech environments.
• Strong knowledge of USP <795>, <797>, <800>, cGMP, and state pharmacy regulations.
• Experience with laboratory investigations and CAPA processes.
• Must be based in or be able to work on-site in Gilbert, Arizona.
• Ability to wear respiratory protection and handle hazardous drugs.

Nice to have

• Experience in 503A compounding pharmacy or 503B outsourcing facilities.
• Familiarity with FDA guidance on sterile compounding.
• Previous supervisory experience leading QC staff.
• Experience with LIMS or electronic quality systems.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO and company holidays.
• Comprehensive medical, dental, and vision insurance.
• 401k benefits with employer matching.
• Employee Stock Purchase Program (ESPP).