Quality Systems Specialist

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 49,593 - 55,104; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Company‑Paid Life Insurance (1x Annual

Voluntary Life Insurance Options

Short‑Term and Long‑Term Disability

FSA & HSA

401(k) Retirement Plan with Company

10 PTO days

10 Paid Holidays

Job summary

Argonaut Manufacturing Services Inc. in Carlsbad, CA is seeking a Quality Systems Specialist to identify, document, and resolve quality issues in sterile drug product manufacturing. You will conduct root-cause analysis, assess risks, and determine CAPAs to ensure strict FDA and cGMP compliance.

The role requires strong analytical writing, excellent communication, and cross‑functional collaboration. On‑site, Monday–Friday with potential overtime; you will lead investigations, audits, and

Qualifications

• Bachelor’s degree in Life Sciences or related field preferred.
• Minimum four years in pharma/biotech manufacturing with GMP investigations.
• Strong writing, analytical, and FDA/ICh guidelines knowledge.
• Excellent attention to detail and cross-functional communication.

Responsibilities

• Lead investigations into batch deviations and out-of-spec events.
• Analyze customer complaints and review production history records.
• Ensure documentation aligns with FDA, cGMP, ISO standards.
• Analyze quality data and present metrics to management.
• Support audits and training; drive CAPA effectiveness.

Skills

Analytical mindset

Root-cause analysis

Technical writing

Communication skills

Education

Bachelor’s degree in Life Sciences or related field

Tools

MasterControl

NetSuite

Job description

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.