Quality Systems Specialist

Quality Systems Specialist

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 $36.00 - $40.00 per hour. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

The Quality Systems Specialist will identify, document, and resolve quality issues, deviations, and non-conformances related to sterile drug product manufacturing operations. They will perform root cause analysis, assess risks, and determine Corrective and Preventive Actions (CAPA) to ensure strict compliance with FDA and cGMP standards. The Quality System Specialist will also participate in internal and external audits (client and supplier) and facilitate any corrective actions identified.

This role is a key Quality contact at Argonaut and requires the ability to independently manage timelines and effectively communicate with team members, cross-functional stakeholders, and clients while helping to maintain site Quality Systems in a state of inspection readiness.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Lead in-depth investigations into batch deviations, out-of-specifications, and product failures
• Oversee the analysis of customer complaints, review production history records, and interview personnel.
• Ensure that investigation documentation and manufacturing processes align with FDA, cGMP, ISO, and other relevant industry standards.
• Analyze and present quality data via metrics and reports to inform management decision-making.
• Assist other departments to successfully investigate and documents investigations.
• Complete accurate and thorough historical searches within quality system to identify similar events and determine trends.
• Lead quality training sessions as needed
• Participate in process improvements associated with investigations
• Support visual inspection of finished product
• Lead internal audit program and assist in hosting and responding to client and regulatory audits
• Other duties may be assigned

Requirements and Qualifications

• Bachelor's degree in Life Sciences (Biology, Chemistry), Engineering, or a closely related field is strongly preferred
• Minimum four (4) years of experience in pharmaceutical or biotech manufacturing, heavily focused on GMP (Good Manufacturing Practices) and performing investigations.
• Strong analytical mindset, root-cause analysis skills, exceptional technical writing, and a solid working knowledge of FDA guidelines and ICH requirements.
• Must have a high attention to detail, and excellent communication skills
• Must be able to effectively communicate within the department and cross-functionally with other divisions
• Experience with Master Control and Net Suite a plus
• Superior attention to detail, organizational skills, and the ability to multi-task in a time-line driven environment
• Ability to make decisions regarding quality of product and material
• Strong initiative and willingness to take ownership and drive projects to completion