QA Specialist, GMP Compliance & CAPA Lead

AstraZeneca plc; Santa Monica (CA); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Short-term incentive

Equity-based awards

401(k) plan

Paid time off

Job summary

AstraZeneca plc is seeking a Specialist, Quality in Tarzana, CA to ensure compliance with quality systems and regulatory guidelines. The role covers QA responsibilities for production and disposition of products manufactured for AstraZeneca, reporting to the QA Manager.

The position requires a BA/BS in biological sciences or related field and 2–4 years GMP industry experience. It emphasizes cGMP knowledge, regulatory excellence and investigations closure, with office-based three-day-per-week

Qualifications

• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Adapt best practices for stage appropriate products.

Responsibilities

• Provide quality assurance support across technical operations functions to assure compliance to the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, with CAPA and VoE, drive timely closure.
• Manage change controls in a phase appropriate manner for clinical stage products supporting quality risk management.
• Provide ILT trainings for GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
• Issue batch record documentation to manufacturing and review QC data for disposition and lot closure.
• Approve equipment alarm acknowledgements, activation and PM/Calibration schedules in asset/alarm systems.
• Review routine material release documentation for quality release of raw materials.

Skills

GMP regulations

Regulatory compliance

CAPA management

Investigations

Change control

Education

BA/BS in biological sciences or related field

Job description

AstraZeneca plc is seeking a Specialist, Quality in Tarzana, CA to ensure compliance with quality systems and regulatory guidelines. The role covers QA responsibilities for production and disposition of products manufactured for AstraZeneca, reporting to the QA Manager.

The position requires a BA/BS in biological sciences or related field and 2–4 years GMP industry experience. It emphasizes cGMP knowledge, regulatory excellence and investigations closure, with office-based three-day-per-week