Quality Assurance Associate II

Argonaut Manufacturing Services • Carlsbad, CA

4d • Onsite

About The Position

The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including leading quality investigations, managing client complaints, and reviewing production batch records and associated documentation required to release a production lot. This role also supports the investigation and resolution of customer complaints, deviations, and internal non-conformance events, helping drive CAPA and continuous improvement efforts. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Hours are 9:00 am - 5:30 pm with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Requirements

• Bachelor's degree in Life Sciences discipline or equivalent is preferred
• Minimum four (4) years of relevant experience
• Must be able to effectively communicate within the department and cross-functionally with other divisions
• High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
• Experience working in the life science and/or pharmaceutical manufacturing industry
• Proven problem-solving skills
• Excellent oral and written communication skills, and listening skills
• Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices
• Ability to make decisions regarding quality of product and material

Nice To Haves

• Experience with MasterControl and NetSuite a plus
• Superior attention to detail, organizational skills, and the ability to multi-task in a time- line driven environment

Responsibilities

• Review production records and associated documentation for lot disposition
• Prepare Certificate of Compliance (COC) and review Certificate of Analysis (COA), as required
• Perform line clearance functions for cGMP processes
• Support manufacturing operations and staff to address product quality and compliance issues, as they arise
• Initiate, lead and/or assist investigations into quality issues such as complaints, Corrective and Preventive Actions (CAPAs), and non-conformances
• Perform visual inspection of finished product
• Manage client complaints
• Oversee facility/cleanroom cleaners to ensure they are fully trained and have documented training for current Argonaut/Aluris procedures, have current unexpired cleaning forms available, and maintain annual gowning requalifications as applicable
• Perform facility walkthroughs to ensure cleanrooms, laboratories, warehouse, etc. remain in compliance

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