Quality Control Specialist, Microbiology (Biotech)

Location: Thousand Oaks, California, United States; onsite laboratory role

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead microbial identification activities, organism assessments, and routine and non-routine microbiological testing.
• Coordinate microbiology laboratory operations, daily priorities, laboratory staff supervision, and weekend support.
• Lead investigations into deviations, environmental monitoring excursions, contamination events, root causes, risks, and product impact.
• Provide technical expertise in environmental monitoring, bioburden control, contamination control strategies, and laboratory controls.
• Author and drive CAPAs, microbial risk assessments, change controls, validation documentation, methods, and SOPs.
• Coordinate contract laboratory testing and partner with Quality, Manufacturing, Engineering, and global microbiology teams on inspections and process improvements.

Requirements

• High school diploma/GED with 10 years of Quality, Microbiology, or Operations experience; associate degree with 8 years; bachelor's degree with 4 years; master's degree with 2 years; or doctorate degree.
• Microbiology laboratory experience, preferably involving microbial identification and contamination control in manufacturing.
• Leadership experience supervising staff, prioritizing laboratory workloads, and supporting microbiological testing.
• Experience with GMP laboratories, regulatory inspections, audit readiness, deviations, analytical test result assessments, and inspection-ready technical writing.
• Proficiency with Veeva, LIMS, LMES, CIMS, SAP, Maximo, and other electronic laboratory and quality systems.
• Experience with aseptic sample aliquoting, laboratory equipment operation and maintenance, validation protocols, and change-controlled documentation.

Nice to have

• Experience leading Operational Excellence initiatives such as 5S and Standard Work.
• Strong project management, presentation, communication, adaptability, and prioritization skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and paid time off.
• Career development opportunities and flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.