Quality Assurance Associate II

Argonaut Manufacturing Services•Carlsbad, CA

18h•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. This role is 100% on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00 am - 9:00 with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

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
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

Nice To Haves

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
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