Quality Specialist (Healthcare/cGMP)

TL;DR

Quality Specialist (cGMP/503B): Providing quality oversight and QMS management for sterile injectable manufacturing with an accent on compliance with FDA and USP standards. Focus on batch record review, aseptic processing monitoring, and maintaining continuous inspection readiness.

Location: On-site in Los Alamitos, California

Salary: $70K – $85K

Company

A leading health and wellness platform redefining healthcare by providing affordable, accessible, and personalized care.

What you will do

• Monitor manufacturing and aseptic processing operations for compliance with cGMP and USP standards on the manufacturing floor.
• Perform batch record review and support product disposition to ensure identity, strength, quality, and purity.
• Manage environmental monitoring (EM) data, including the escalation of excursions and adverse trends.
• Author, revise, and maintain GMP documentation and SOPs within a compliant repository.
• Initiate and document deviations, OOS, and CAPAs, utilizing root cause analysis.
• Participate in internal and external regulatory audits to ensure continuous inspection readiness.

Requirements

• Must be based in Los Alamitos, California (On-site).
• 2+ years of experience in Quality Assurance or Quality Control within an FDA-regulated environment.
• Working knowledge of FDA cGMP (21 CFR Parts 210, 211, 11) and Section 503B of the FD&C Act.
• Experience with USP-NF standards and aseptic processing principles.
• Proficiency in batch record review and core quality system elements (deviations, CAPA, change control).
• Strong technical writing and documentation skills.

Culture & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• 401k with employer matching contribution and Employee Stock Purchase Program (ESPP).
• Offsite team retreats.