Quality Assurance Associate II

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 74,000 - 80,000; 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 & Health Savings Account

401(k) Retirement Plan with Company M

10 Days of Paid Time Off

10 Paid Holidays Annually

Job summary

Argonaut Manufacturing Services Inc. is seeking a Quality Assurance/Compliance Specialist to ensure quality requirements are met. The role leads quality investigations, manages client complaints, and reviews production batch records to support release of production lots.

The position is on-site, Monday through Friday, 8 hours per day, with possible overtime, weekends, or holidays as needed. Ideal candidates have a Life Sciences background, 4+ years of relevant experience, and strong knowledge of

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• Minimum four years of relevant experience.
• Experience in life science/pharmaceutical manufacturing.
• Strong communication and cross-functional collaboration.
• Knowledge of cGMP, 21 CFR 820, ISO 13485 and good documentation practices.

Responsibilities

• Review production records and documentation for lot disposition.
• Prepare Certificates of Compliance and review Certificates of Analysis.
• Perform line clearance for cGMP processes.
• Support manufacturing operations to address quality and compliance issues.
• Lead investigations into quality issues, CAPAs, and non-conformances.
• Perform visual inspection of finished product.
• Manage client complaints.
• Oversee cleaning procedures and training compliance.
• Conduct facility walkthroughs to ensure compliance.

Skills

Communication

Attention to detail

Problem solving

Multi-tasking

Oral & written comms

Education

Bachelor's in Life Sciences

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 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 $74,000 - $80,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

Position Overview

The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including leading quality investigations, managing client complaints, and reviewing production batch records and associated documentation required to release a production lot. This role also supports the investigation and resolution of customer complaints, deviations, and internal non-conformance events, helping drive CAPA and continuous improvement efforts.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Hours are 9:00 am - 5:30 pm with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Review production records and associated documentation for lot disposition
• Prepare Certificate of Compliance (COC) and review Certificate of Analysis (COA), as required
• Perform line clearance functions for cGMP processes
• Support manufacturing operations and staff to address product quality and compliance issues, as they arise
• Initiate, lead and/or assist investigations into quality issues such as complaints, Corrective and Preventive Actions (CAPAs), and non-conformances
• Perform visual inspection of finished product
• Manage client complaints
• Oversee facility/cleanroom cleaners to ensure they are fully trained and have documented training for current Argonaut/Aluris procedures, have current unexpired cleaning forms available, and maintain annual gowning requalifications as applicable
• Perform facility walkthroughs to ensure cleanrooms, laboratories, warehouse, etc. remain in compliance

Requirements and Qualifications

• Bachelor's degree in Life Sciences discipline or equivalent is preferred
• Minimum four (4) years of relevant experience
• Must be able to effectively communicate within the department and cross-functionally with other divisions
• High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
• Experience with MasterControl and NetSuite a plus
• Superior attention to detail, organizational skills, and the ability to multi-task in a time- line driven environment
• Experience working in the life science and/or pharmaceutical manufacturing industry
• Proven problem-solving skills
• Excellent oral and written communication skills and listening skills
• Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices
• Ability to make decisions regarding quality of product and material

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 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.