Quality Assurance Associate

Quality Assurance Associate

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

The pay range for this position is $32.00 - $34.00 per hour. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

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.

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 8:00 am - 9:00 with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• 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

Requirements and Qualifications

• 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

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

As a condition of employment, employees are required to review and sign certain company agreements and policies, including a confidential information agreement and an arbitration agreement for the resolution of employment-related disputes, in accordance with applicable law.

Background checks are conducted to support workplace productivity, safety, and security by ensuring applicant backgrounds and qualifications are suitable for the position being considered.

It is the policy of Argonaut Manufacturing Services, Inc., as part of its hiring procedures, to conduct background checks on finalist(s) for all positions. These checks will be job-related, consistent with business necessity, and conducted pursuant to all applicable laws, rules, policies, and procedures. Background checks may include, but are not limited to, verification with educational institutions or licensing/credentialing boards; standard criminal checks; employment verification; and other pertinent information and resources.

Employment offers will generally be made after successful completion of applicable background check(s). However, any offers of employment made prior to completion of the background check(s) shall be contingent upon successful completion of the check(s). Finalist(s) may be rejected if they provide inaccurate or untruthful information, do not fully participate in a required background check, or do not sign or complete a required form.