Quality Assurance Associate

Argonaut Manufacturing Services•Carlsbad, CA

11d•Onsite

About The Position

The Quality Assurance Associate plays a key role in supporting product quality and compliance activities within a regulated environment. This position is responsible for management and coordination of documents and training through Argonaut's eQMS (MasterControl). MasterControl is validated, FDA compliant, and meets regulatory standards for electronic document control (21 CFR Part 11). This role also supports the investigation and resolution of customer complaints, deviations, and non-conformance events, helping drive CAPA and continuous improvement efforts. Other duties include performing visual inspection of finished products. 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 similar. Active years of experience in a cGMP laboratory or manufacturing role will be taken into consideration in lieu of education.
2 years of Quality Assurance experience, preferably within the medical device, biotechnology, or pharmaceutical industry strongly preferred
Working knowledge of MasterControl strongly preferred
Understanding of 21 CFR 201/211 regulatory guidelines
Strong knowledge of batch record review, material release, deviations, non-conformance reporting, and CAPA processes
Familiarity with root cause investigation tools and problem-solving methodologies
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

Responsibilities

Create, revise, and maintain controlled documents, including SOPs, forms, and reports
Issue part number, lot numbers, and batch records to production
Create and produce product labels
Collaborate cross-functionally with Manufacturing, QC, and other departments to resolve quality-related issues
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
Support internal and external audits, ensuring timely and effective resolution of findings
Review, scan and file miscellaneous quality documentation
Perform line clearance activities