What are the responsibilities and job description for the Senior Quality Assurance Associate position at Argonaut Manufacturing Services Inc.?
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 Vacation ✔ 10 Paid Holidays Annually
The pay range for this position is $85,000.00 - $95,000.00 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 reviewing and approving validation reports, conducting internal and external audits, and review of production batch records and associated documentation required to release a production lot. This position will provide quality oversight for second shift GMP manufacturing so must be able to work independently, manage time appropriately, and be able to make decisions regarding product quality.
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 6:00 am – 8:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.
Responsibilities And Duties
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.
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 Vacation ✔ 10 Paid Holidays Annually
The pay range for this position is $85,000.00 - $95,000.00 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 reviewing and approving validation reports, conducting internal and external audits, and review of production batch records and associated documentation required to release a production lot. This position will provide quality oversight for second shift GMP manufacturing so must be able to work independently, manage time appropriately, and be able to make decisions regarding product quality.
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 6:00 am – 8:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.
Responsibilities And Duties
- Review production batch record and associated documentation for lot disposition
- Investigate discrepancies and ensure all issues are resolved
- Prepare Certificate of Compliance (COC) or 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
- Lead and/or assist investigations into quality issues such as complaints and Corrective and Preventive Actions (CAPAs)
- Perform visual inspection of finished product
- High school diploma is required. Bachelor's degree is strongly preferred in a Life Sciences discipline or equivalent
- Minimum five (5) years of Quality experience, preferably batch review 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
- 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
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.
Salary : $85,000 - $95,000