Quality Systems Specialist

Argonaut Manufacturing Services • Carlsbad, CA

7d • Onsite

About The Position

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. The 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.

Requirements

• 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
• 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

Nice To Haves

• Experience with MasterControl and NetSuite a plus

Responsibilities

• 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

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