Manufacturing Quality Assurance Associate II

Genentech • Oceanside, CA

18h • Onsite

About The Position

The Manufacturing Quality Assurance Associate II provides QA support and oversight for manufacturing operations to ensure compliance with good business practices, applicable health authority regulations, approved SOPs, and cGMP standards. The role supports the consistent delivery of Oceanside products that meet customer and regulatory requirements, resolves GMP issues, contributes to process improvements and strategic initiatives, and builds productive working relationships across the company.

The position oversees manufacturing documentation and deviations, reviews and approves batch records and batch reports, and supports quality issues involving raw materials, in-process materials, bulk and final products, environmental conditions, and systems. It also evaluates product quality impact, recommends material dispositions and corrective actions, contributes to change control and SOP activities, and supports internal and regulatory inspections. The essential functions are performed in an office environment, with gowning required when working in clean-room environments. Two onsite schedule options are available: Sunday–Wednesday or Wednesday–Saturday, with day or swing schedules of four 10-hour days based on business need.

Requirements

• Bachelor's degree; Biology or Biochemistry preferred.
• At least 4 years of relevant pharmaceutical industry experience.
• Comprehensive knowledge of GMPs, Standard Operating Procedures (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.
• Demonstrated ability to independently manage and influence multiple projects simultaneously.
• Proficiency in utilizing computer-based systems.

Nice To Haves

• Biology or Biochemistry degree.

Responsibilities

• Resolve GMP issues observed during manufacturing through higher-level interactions with multiple Genentech departments.
• Review and approve batch records and batch reports.
• Participate as a QA representative in cross-functional meetings related to process improvement and operational activities.
• Provide QA support to resolve issues involving raw materials, in-process materials, bulk and final products, environmental conditions, and systems.
• Provide QA oversight of deviations and work with deviation owners to ensure requirements for closure are met.
• 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 activities related to Change Control.
• 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 company benefits detailed at the linked benefits page.

What This Job Offers

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