Quality Systems 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 serves highly innovative companies in the biopharmaceutical and molecular diagnostics industries, providing full‑service, cost‑effective solutions in formulation, filling, and final kitting of reagents and consumables. Argonaut delivers quality and regulatory expertise to ensure the highest levels of manufacturing and supply chain excellence. Benefits and Pay Range 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 $36.00 - $40.00 per hour, with actual compensation based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The Quality Systems Specialist identifies, documents, and resolves quality issues, deviations, and non‑conformances related to sterile drug product manufacturing operations. The role conducts root‑cause analysis, assesses risks, and determines Corrective and Preventive Actions (CAPA) to ensure strict compliance with FDA and cGMP standards. The specialist participates in internal and external audits and facilitates corrective actions identified during audits. This key quality contact independently manages timelines, communicates with team members, cross‑functional stakeholders, and clients, and maintains site Quality Systems in an inspection‑ready state. The position is on‑site Monday‑Friday, 8 hours/day (excluding lunch). Overtime, weekends, and holidays may be required; flexible start time between 7:00 am and 9:00 am with a consistent schedule is expected. Responsibilities and Duties Lead in‑depth investigations into batch deviations, out‑of‑specifications, and product failures. Oversee analysis of customer complaints, review production history records, and interview personnel. Ensure investigation documentation and manufacturing processes align with FDA, cGMP, ISO, and other industry standards. Analyze and present quality data via metrics and reports to inform management decision‑making. Assist other departments to successfully investigate and document investigations. Complete accurate and thorough historical searches within the quality system to identify similar events and determine trends. Lead quality training sessions as needed. Participate in process improvements associated with investigations. Support visual inspection of finished product. Lead internal audit program and assist in hosting and responding to client and regulatory audits. Perform other duties as assigned. Requirements and Qualifications Bachelor’s degree in Life Sciences (Biology, Chemistry), Engineering, or a closely related field is strongly preferred. Minimum four (4) years of experience in pharmaceutical or biotech manufacturing, heavily focused on GMP and performing investigations. Strong analytical mindset, root‑cause analysis skills, exceptional technical writing, and a solid working knowledge of FDA guidelines and ICH requirements. High attention to detail and excellent communication skills. Ability to communicate effectively within the department and cross‑functionally with other divisions. Experience with MasterControl and NetSuite is a plus. Superior attention to detail, organizational skills, and the ability to multi‑task in a time‑line driven environment. Ability to make decisions regarding quality of product and material. Strong initiative and willingness to take ownership and drive projects to completion. Equal Employment Opportunity Statement 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 with all employment eligibility verification requirements of the Immigration and Nationality Act and requires authorization to work in the U.S. Employment Agreements and Background Check Policy As a condition of employment, employees are required to review and sign company agreements and policies, including a confidential information agreement and an arbitration agreement, in accordance with applicable law. Background checks are conducted to support workplace productivity, safety and security. These checks will be job‑related, consistent with business necessity, and conducted pursuant to all applicable laws, rules, policies, and procedures. Eligibility offers are contingent upon successful completion of background checks. #J-18808-Ljbffr Argonaut Manufacturing Services Inc.