Quality Systems Lead - GMP & CAPA Expert

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

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