Manufacturing Quality Assurance Associate II

Roche • Oceanside, CA

1d • $67,300 - $124,900 • Onsite

About The Position

The Manufacturing Quality Assurance (MQA) Associate II provides quality assurance support and oversight for manufacturing operations to ensure compliance with good business practices, applicable health authority regulations, approved SOPs, and cGMP standards. The role uses technical expertise to resolve manufacturing issues, develop solutions, support process improvements and strategic initiatives, and maintain productive working relationships across the company. It oversees manufacturing documentation and deviations and helps ensure Oceanside products meet customer and regulatory requirements.

Two on-site positions are available, with schedules of Sunday–Wednesday or Wednesday–Saturday. The schedule may be a day or swing schedule, based on business need, consisting of four 10-hour days. Essential functions take place in an office environment, with required gowning when working in clean rooms. The position may involve exposure to hazardous materials and chemicals and lifting up to 30 pounds. Relocation benefits are available. The expected annual salary range for the primary California location is $67,300–$124,900; actual pay depends on experience, qualifications, geographic location, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance.

Requirements

• Bachelor's degree; Biology or Biochemistry preferred.
• Minimum 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, Good Manufacturing Practices (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 using computer-based systems.
• Ability to meet the physical demand of lifting up to 30 pounds.
• Ability to wear required clean-room attire, including hospital scrubs, bunny suits, gloves, and steel-toe boots; makeup and jewelry are not permitted in the clean-room environment.

Responsibilities

• Perform higher-level interactions 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 concerning 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 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 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 company benefits detailed at a provided link.

What This Job Offers

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