Quality Assurance Specialist II - GMP & CAPA Lead

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

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