Quality Assurance Associate

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company serves highly innovative biopharmaceutical and molecular diagnostics companies as a full-service, cost‑effective partner, providing solutions in formulation, filling, and final kitting of reagents and consumables while upholding quality and regulatory excellence.

At Argonaut Manufacturing Services we value our employees and offer a comprehensive benefits package to support well‑being and financial security.

• 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

The pay range for this position is $32.00 – $34.00 per hour. Compensation is based on location, skills, education, experience, and other relevant qualifications.

As a Quality Assurance Associate, you will support product quality and compliance activities in a regulated environment. Your responsibilities include managing documents and training through Argonaut’s eQMS (Master Control), investigating customer complaints, deviations, and non‑conformance events to drive CAPA and continuous improvement, and performing visual inspections of finished products.

You will report to the Director of Quality Assurance, working cross‑functionally to ensure cGMP and ISO compliance, audit readiness, and overall effectiveness of the quality management system. Strong problem‑solving skills and the ability to manage multiple priorities in a fast‑paced environment are essential.

This 100% on‑site role is Monday‑Friday, 8 hours/day (excluding lunch). Overtime, weekends, and holidays may be required. Flexible start time between 8:00 am and 9:00 am with a consistent schedule.

• Create, revise, and maintain controlled documents, including SOPs, forms, and reports
• Issue part numbers, 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

• Bachelor’s degree in a scientific discipline or equivalent; active years of experience in a cGMP laboratory or manufacturing role will be considered in lieu of education.
• At least 2 years of Quality Assurance experience, preferably in medical device, biotechnology, or pharmaceutical industry.
• Working knowledge of Master Control 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 for effective cross‑functional collaboration.
• 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 authorization to work in the US.