Senior Associate Quality Assurance / Aseptic Coach (Biotech)

Location: Thousand Oaks, California, United States; onsite role supporting a 24/7 manufacturing facility with rotating day, swing, and graveyard shifts, including weekends.

Salary: $82,081.95–$111,052.05 USD annually

Company

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

What you will do

• Provide daily Quality Assurance oversight for drug product manufacturing operations.
• Perform real-time aseptic oversight and coach filling activities on the manufacturing floor.
• Support gowning, manual visual inspection, ASP/AQL performance, and QA oversight assessments in a Grade 8 clean room.
• Troubleshoot and triage quality and aseptic compliance issues, including non-routine interventions.
• Review and approve electronic batch records, MES documentation, GMP documents, maintenance work orders, and minor deviations.
• Support quality-related decision-making and process execution in alignment with regulatory requirements.

Requirements

• High school diploma/GED plus 4 years of GMP experience, or an associate degree plus 2 years of GMP experience, or a bachelor's degree plus 6 months of GMP experience; a master's degree is also listed.
• Experience with GMP operations, detailed SOPs, training requirements, and good documentation practices.
• Ability to evaluate documentation and operations according to company procedures and work with quality systems.
• Strong organizational, written, verbal communication, teamwork, and independent-working skills.
• Ability to apply aseptic behaviors and principles and support production in a Grade 8 clean-room filling facility.
• Flexibility for rotating 8- to 12-hour shifts, including weekends and day, swing, and graveyard rotations, is required.

Nice to have

• Bachelor's degree in biochemistry, biology, chemistry, or a related science field.
• Experience managing projects through completion and meeting timelines.
• Leadership skills and experience driving improvement initiatives.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Time-off plans and career development opportunities.
• Sponsorship for this role is not guaranteed.