Manufacturing Quality Assurance Associate II

Genentech • Oceanside, CA

1d • $67,300 - $124,900 • Onsite

About The Position

Genentech is seeking a technically adept Manufacturing Quality Assurance (MQA) Associate II to provide quality assurance support and oversight for manufacturing processes. The role helps ensure compliance with good business practices, cGMP standards, applicable health authority regulations, and customer requirements for products manufactured in Oceanside. The associate will resolve manufacturing quality issues, support process improvements and strategic initiatives, and maintain productive working relationships across the company.

The position oversees manufacturing documentation and deviations, and helps ensure facilities and operational systems align with approved SOPs and cGMP standards. It includes batch record review and approval, quality support across materials and products, deviation oversight, change control, and support for regulatory and internal inspections.

Two onsite positions are available, with schedules of Sunday–Wednesday or Wednesday–Saturday. The schedule may be a day or swing schedule, based on business need, working four 10-hour days. Essential functions take place in an office environment, with gowning required for clean-room work. Relocation benefits are available. The expected annual salary range for the primary California location is $67,300–$124,900. A discretionary annual bonus may be available based on individual and company performance.

Requirements

• Bachelor's degree; Biology or Biochemistry is preferred.
• Minimum of 4 years of relevant pharmaceutical industry experience.
• Comprehensive knowledge of GMPs, SOPs, Quality Systems, and general compliance principles.
• Demonstrated understanding of Quality Assurance, GMPs, health authority regulations, and validation principles and practices.
• Strong interpersonal and communication skills, including the ability to resolve conflicts calmly, diplomatically, and tactfully in team settings.
• Ability to independently manage and influence multiple projects simultaneously.
• Proficiency with computer-based systems.

Nice To Haves

• Bachelor's degree in Biology or Biochemistry.

Responsibilities

• Interact with multiple Genentech departments to resolve GMP issues observed during manufacturing processes.
• Review and approve batch records and batch reports.
• Participate as a QA representative in cross-functional meetings for process improvement and operational activities.
• Provide QA support to resolve raw material, in-process material, bulk and final product, environmental, and system issues.
• Provide QA oversight of deviations and work with deviation owners to ensure requirements are met for closure.
• Review final evaluations and written summaries assessing product quality impact in accordance with Roche and regulatory standards; recommend material dispositions and identify timely corrective actions.
• Participate in routine and non-routine meetings and projects to communicate and resolve system and quality issues related to deviations and improvement projects.
• Support FDA, regulatory, and internal inspection activities as needed.
• Write and revise SOPs, including Change Control activities.
• Assess and approve changes associated with Change Control activities.

Benefits

• Relocation benefits are available.
• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at the provided benefits link.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level