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.
Benefits and Pay Range
At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy:
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
The pay range for this position is $105,000 - $115,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.
Position Overview
We are seeking a Technical Writer 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 8:00am and 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.
Responsibilities and Duties
InvestigationsContinuous 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
DocumentationQuality 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, 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)
Preferred Qualifications
Experience in a contract manufacturing (CDMO/CMO) environment supporting multiple clients
Experience supporting regulatory inspections and client audits
Experience using Enterprise resource planning (ERP) data in investigations
Knowledge, SkillsAbilities
Strong analytical thinking and problem-solving skills
Excellent written and verbal communication
Ability to manage multiple priorities and concurrent investigations
Strong attention to detail and organizational skills
Sound judgment balancing compliance, quality, and business needs
Ability to work independently with minimal supervision
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.
