Manufacturing Investigations & Continuous Improvement Specialist

Corporate Overview

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.

Position Overview

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.

This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

The pay range for this position is between $105,000 - $115,000 annually. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Responsibilities and Duties

Investigations & Continuous Improvement

• 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

Documentation & Quality Systems

• 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

Cross-Functional Collaboration

• 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

Requirements and Qualifications

• 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

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 will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

As a condition of employment, employees are required to review and sign certain company agreements and policies, including a confidential information agreement and an 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.

It is the policy of Argonaut Manufacturing Services, Inc., as part of its hiring procedures, to conduct background checks on finalist(s) for all positions. These checks will be job-related, consistent with business necessity, and conducted pursuant to all applicable laws, rules, policies, and procedures. Background checks may include, but are not limited to, verification with educational institutions or licensing/credentialing boards; standard criminal checks; employment verification; and other pertinent information and resources.

Employment offers will generally be made after successful completion of applicable background check(s). However, any offers of employment made prior to completion of the background check(s) shall be contingent upon successful completion of the check(s). Finalist(s) may be rejected if they provide inaccurate or untruthful information, do not fully participate in a required background check, or do not sign or complete a required form.