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
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, 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, Skills & Abilities
- 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
