Quality Systems Specialist

Job Description

Job Description

Corporate OverviewArgonaut 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 RangeAt 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 $71K - $80K annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.Position OverviewThe Quality Systems Specialist will identify, document, and resolve quality issues, deviations, and non-conformances related to sterile drug product manufacturing operations. They will perform root cause analysis, assess risks, and determine Corrective and Preventive Actions (CAPA) to ensure strict compliance with FDA and cGMP standards. The Quality System Specialist will also participate in internal and external audits (client and supplier) and facilitate any corrective actions identified.The role is a key Quality contact at Argonaut and requires the ability to independently manage timelines and effectively communicate with team members, cross-functional stakeholders, and clients while helping to maintain site Quality Systems in a state of inspection readiness.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. Exceptions to the schedule must be approved by the manager in advance.Responsibilities and DutiesLead investigations into batch deviations, out-of-specification results, and product failures by independently evaluating evidence, determining root causes, assessing product impact, and recommending appropriate corrective and preventive actions (CAPAs).Direct and conduct investigations of customer complaints by reviewing manufacturing records, interviewing personnel, evaluating potential product impact, and determining appropriate investigative strategies and follow-up actions.Interpret and apply FDA, cGMP, ISO, and other regulatory requirements to ensure investigation outcomes, documentation, and quality system activities remain compliant and inspection ready.Analyze quality system trends and performance metrics, evaluate operational risks, and provide recommendations to management regarding quality improvements and regulatory compliance.Serve as the Quality lead by providing technical guidance to cross-functional teams during investigations and ensuring investigations meet regulatory and quality system requirements.Lead quality training sessions as neededEvaluate investigation processes and recommend and implement improvements that enhance regulatory compliance, operational efficiency, and overall quality system effectivenessLead internal audit program; assist in hosting and responding to client and regulatory auditsOther duties may be assignedRequirements and QualificationsBachelor 's degree in Life Sciences (Biology, Chemistry), Engineering, or a closely related field is strongly preferredLevel II Associate: 2 - 4 years of experience in pharmaceutical or biotech manufacturing, heavily focused on GMP (Good Manufacturing Practices) and performing investigations.Analytical mindset, root-cause analysis skills, exceptional technical writing, and a solid working knowledge of FDA guidelines and ICH requirements.Must have a high attention to detail, and excellent communication skillsMust be able to effectively communicate within the department and cross-functionally with other divisionsExperience with MasterControl and NetSuite a plusSuperior 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 materialStrong initiative and willingness to take ownership and drive projects to completionArgonaut 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.