Manufacturing QA Associate II - Process & Compliance

Genentech; Oceanside (CA); On-site; USD 67,000 - 125,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Oceanside, CA, seeks a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMPs and health authority regulations. On-site positions are available Sunday-Wednesday or Wednesday-Saturday, four 10-hour days based on business need.

You will oversee manufacturing documentation, deviations, batch reviews, and change controls, and participate in cross-functional teams to drive process improvements. Relocation benefits available.

Qualifications

• Bachelor's degree in Biology or Biochemistry; 4+ years pharmaceutical industry experience.
• Strong knowledge of GMPs, SOPs, Quality Systems and compliance principles.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Oversee manufacturing documentation and deviations.
• Review batch records and batch reports.
• Participate in cross-functional QA meetings for improvements.
• Provide QA support for raw materials, in-process materials, bulk and final product issues.
• Support FDA/Regulatory and internal inspection activities.
• Write and revise SOPs and Change Control activities.

Skills

Interpersonal communication

Project management

Computer-based systems

Education

Bachelor's degree in Biology or Biochemistry

Job description

Genentech in Oceanside, CA, seeks a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMPs and health authority regulations. On-site positions are available Sunday-Wednesday or Wednesday-Saturday, four 10-hour days based on business need.

You will oversee manufacturing documentation, deviations, batch reviews, and change controls, and participate in cross-functional teams to drive process improvements. Relocation benefits available.