Senior QA Associate - Drug Product Manufacturing (GMP)

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision

Life insurance

FSA

Discretionary bonus

Stock-based incentives

Paid time off

Flexible work model

Job summary

Amgen, a leader in biotech, is seeking a Senior Associate Quality Assurance to provide daily QA oversight in a Drug Product manufacturing facility. The role requires adherence to SOPs, GMP standards, and strong documentation practices to ensure regulatory compliance.

You will participate in electronic batch reviews, approvals of QA documentation, and support for deviations. Flexible shifts and a focus on quality will be essential to maintain continuous production.

Qualifications

• Bachelor's degree in Biochemistry, Biology, Chemistry or related field is preferred.
• Experience following detailed SOPs, maintaining training and good documentation practices.
• Experience managing projects through to completion and meeting timelines.
• Familiarity with Quality Systems and GMP operations.

Responsibilities

• Oversee QA of Drug Product manufacturing areas and ensure processes align with regulatory requirements.
• Electronic batch review and approval of electronic maintenance documentation.
• Review and approve SOPs/ FORMs and QA documentation revisions.
• Support deviations, batch records, and quality record completion.
• Assist in 24/7 production support with shift flexibility.

Skills

GMP operations

SOP adherence

Documentation

Quality systems

Project management

Communication

Education

Bachelor's in Biochemistry, Biology, Chemistry, or related science

Master's

High school/GED with GMP experience

Associates + GMP experience

Job description

Amgen, a leader in biotech, is seeking a Senior Associate Quality Assurance to provide daily QA oversight in a Drug Product manufacturing facility. The role requires adherence to SOPs, GMP standards, and strong documentation practices to ensure regulatory compliance.

You will participate in electronic batch reviews, approvals of QA documentation, and support for deviations. Flexible shifts and a focus on quality will be essential to maintain continuous production.