Quality Assurance Associate II

Argonaut Manufacturing Services • Carlsbad, CA

1d • Onsite

About The Position

The Quality Assurance Associate II plays a key role in supporting product quality and compliance activities within a regulated environment. This position is responsible for batch record review and release, as well as the creation and revision of technical documentation, including SOPs, specifications, and reports. This role also supports the investigation and resolution of customer complaints, deviations, and internal non-conformance events, helping drive CAPA and continuous improvement efforts. Reporting to the Director of Quality Assurance, this position works cross-functionally to ensure compliance with cGMP and ISO standards, supports audit readiness, and contributes to the overall effectiveness of the quality management system. This role requires a detail-oriented, hands-on professional with strong problem-solving skills and the ability to manage priorities in a fast-paced environment.

Requirements

• Bachelor's degree in a scientific discipline or related field preferred
• 4+ years of Quality Assurance experience, preferably within the medical device, biotechnology, or pharmaceutical industry
• Experience working in a cGMP and/or ISO 13485 regulated environment
• Strong knowledge of batch record review, materials release, deviations, non-conformance reporting, and CAPA processes
• Familiarity with root cause investigation tools and problem-solving methodologies
• Experience with document control, change control, and quality management systems
• Working knowledge of eQMS systems, including MasterControl or similar platforms, preferred
• Experience supporting product transfers, new product introductions, or process validation activities preferred
• Familiarity with LIMS, ERP systems, and manufacturing applications is a plus
• Strong understanding of Good Documentation Practices (GDP) and quality record management
• Excellent verbal and written communication skills with the ability to work effectively across cross-functional teams
• Strong organizational skills, attention to detail, and ability to manage multiple priorities under tight timelines
• Self-motivated with strong initiative, problem-solving abilities, and a hands-on approach
• Knowledge of Lean Manufacturing principles, 5S, or lab space optimization is a plus

Responsibilities

• Review and release batch production records in compliance with cGMP and internal quality standards
• Create, revise, and maintain controlled documents, including SOPs, specifications, and reports
• Support internal and external audits, ensuring timely and effective resolution of findings
• Investigate deviations, non-conformances, and customer complaints; drive root cause analysis and implement CAPA
• Monitor and trend quality data to identify areas for improvement and support continuous improvement initiatives
• Maintain and support quality systems, including document control, change control, and CAPA processes
• Collaborate cross-functionally with Manufacturing, QC, and other departments to resolve quality-related issues
• Provide guidance on product quality concerns and recommend corrective and preventive actions
• Ensure compliance with cGMP, ISO 13485, and company quality standards
• Support new product introductions, transfers, and validation activities as needed
• Promote adherence to good documentation practices and ensure accuracy of quality records

Benefits

• Medical, Dental, and Vision Insurance
• Company-Paid Life Insurance (1x Annual Salary)
• Voluntary Life Insurance Options
• Short-Term and Long-Term Disability Insurance
• Flexible Spending Account (FSA) & Health Savings Account (HSA)
• 401(k) Retirement Plan with Company Matching
• 10 Days of Paid Time Off (PTO)
• 10 Paid Holidays Annually

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level