Senior Quality Control Associate - Chemistry

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.

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 $130,000 - $140,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

The purpose of this position is to provide support services by executing analysis of in‑process, finished product and stability test samples. Further support services include processing and testing of environmental monitoring and raw material samples. QC personnel are responsible for compliance to QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control.

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.

• Management of incoming samples utilizing a laboratory information system (LIMS) or other means.
• Perform detailed chemical analysis of samples from production, routine monitoring, stability and validation or qualification studies using compendial and non‑compendial methods.
• Utilize advanced instruments such as HPLC/UHPLC, SoloVPE, Maurice (cIEF and SDS Page), FTIR and UV/Vis Spectrophotometers.
• Author protocols and reports including but not limited to method qualification, method verification, method validation and method suitability.
• Apply and adhere to data integrity principles to sample handling and analysis.
• Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements.
• Author and revise QC related SOPs as required.
• Interface with product sponsors on QC related inquiries.
• Participate in the review and approval of Manufacturing Batch Records for QC related activities.
• Execute analytical method transfer activities, including product‑specific test methods.
• Train junior personnel in appropriate laboratory and safety procedures.
• Execute Installation and Operational Qualification of analytical instrumentation where applicable.
• Directly contribute to daily laboratory operations for QC Chemistry in full compliance with applicable SOPs and safety guidelines.

• Undergraduate degree (B.A. or B.S.) in a Life Science discipline.
• A minimum of 7 years’ experience in a GMP‑compliant Quality Control function within the medical device and/or biopharmaceutical fields.
• A high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
• Analytical experience in buffer characterization (pH, conductivity, osmolality), concentration (UV/Vis and/or fluorescence) and chromatography (HPLC, electrophoresis).
• The ability to work effectively within cross‑functional teams comprised of Manufacturing, Tech Transfer, Quality Assurance, and Senior Management.
• An affinity for precise and detailed documentation skills.
• The ability to effectively influence and contribute…