Manufacturing Investigations & Continuous Improvement Specialist

Argonaut Manufacturing Services • Carlsbad, CA

11d • Onsite

About The Position

We are seeking a Manufacturing Investigations & Continuous Improvement Specialist to join our onsite manufacturing organization in a fast-paced contract manufacturing (CMO/CDMO) environment. This role is responsible for leading high-quality cGMP investigations, driving root cause elimination, and implementing sustainable corrective and preventative actions (CAPAs). The Specialist will play a critical role in advancing continuous improvement initiatives, enhancing process robustness, and improving process reliability. The ideal candidate combines strong technical writing, analytical problem-solving, and cross-functional collaboration to ensure regulatory compliance, reduce recurring quality events, and support inspection readiness.

Requirements

• Bachelor's degree in biology, Chemistry, Engineering, or related scientific discipline
• 5+ years of experience in investigations in a cGMP manufacturing, quality, or continuous improvement role (CMO/CDMO experience preferred)
• Demonstrated experience leading GMP investigations and authoring deviations, non-conformances, complaints, CAPAs, and change controls
• Strong technical writing skills with the ability to translate complex technical information into clear, compliant documentation
• Hands-on experience with root cause analysis tools (5 Whys, Fishbone, FMEA) and data trending/metrics analysis
• Working knowledge of cGMP regulations, FDA expectations, and Quality Systems
• Proven ability to collaborate effectively in a cross-functional, onsite manufacturing environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Experience with eQMS/document management systems (MasterControl preferred)
• Experience in a contract manufacturing (CDMO/CMO) environment supporting multiple clients

Nice To Haves

• CMO/CDMO experience preferred

Responsibilities

• Lead end-to-end cGMP investigations (deviations, non-conformances, complaints) with a focus on root cause identification, risk mitigation, and prevention of recurrence
• Apply structured root cause methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify systemic issues and drive continuous improvement
• Develop, implement, and track CAPAs, ensuring effectiveness, sustainability, and measurable outcomes
• Analyze and trend data to identify recurring issues and improvement opportunities
• Evaluate and collaborate on cGMP-compliant documentation, including SOPs, production records, studies, validation protocols, and reports
• Initiate and manage change controls in support of process, equipment, and continuous improvement initiatives
• Ensure documentation meets cGMP and FDA regulatory expectations, with a focus on clarity, accuracy, and compliance
• Partner with Manufacturing, Engineering, MSAT, Facilities, Finance and Quality to implement process improvements
• Contribute to inspection readiness by maintaining high-quality investigation and documentation standards
• Lead interdepartmental continuous improvement initiatives

Benefits

• Equal opportunity employer (EEO) committed to providing employment opportunities 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.
• Complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
• Confidential information agreement
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level