Manufacturing Quality Assurance Associate II

Please note there are 2 on-site positions available (Sunday-Wednesday, Wednesday-Saturday), which can be a day or swing schedule (4 days x 10 hours) based on business need.

The Opportunity

As an MQA Associate II you will leverage your strong technical background to resolve issues and devise innovative solutions, ensuring our Oceanside products consistently meet both customer and regulatory requirements. You will also spearhead process improvements, participate in strategic initiatives, and build productive working relationships within the company. Your responsibilities will include overseeing manufacturing documentation, managing deviations, and ensuring our facilities and operational systems align with approved SOPs and cGMP standards. Additionally, you will:

• Perform higher-level interactions with multiple Genentech departments to resolve any GMP issues observed during manufacturing processes.
• Perform batch record and batch report review and approval.
• Participate in cross-functional team meetings for such events as process improvement and/or operational activities as a QA representative.
• Provide Quality Assurance support for resolving raw material, in-process material, bulk and final product, environmental, and system issues.
• Provide QA oversight of deviations, working with deviation owners to ensure all requirements are met for closure.
• Review final evaluations and written summaries that assess product quality impact consistent with Roche and regulatory standards, recommending material dispositions, and identifying timely corrective actions.
• Participate in routine/non-routine meetings and projects with groups to communicate and resolve system and quality issues tied 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.

Who You Are

• You possess a Bachelor's degree (Biology or Biochemistry preferred) and a minimum of 4 years of relevant of pharmaceutical industry experience.
• You have comprehensive knowledge of GMPs, Standard Operating Procedures (SOPs), Quality Systems, and general compliance principles.
• You have demonstrated understanding of Quality Assurance, Good Manufacturing Practices (GMPs), Health Authority Regulations, and Validation principles/practices.
• You possess strong interpersonal and communication skills, with the ability to resolve conflicts calmly, diplomatically, and tactfully in team settings.
• You have a demonstrated ability to independently manage and influence multiple projects simultaneously.
• You are proficient in utilizing computer-based systems.

Work Environment/Physical Demands/Safety Considerations

• The essential functions of this role will be in an office environment.
• The essential functions of this role requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots be worn. Note: No makeup or jewelry may be worn when working in the clean room environment.
• You may be exposed to hazardous materials and chemicals.
• You may be required to lift up to 30lbs.