Manufacturing Quality Assurance Associate II

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 67,000 - 125,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Genentech is seeking a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMP and health authority regulations in our Oceanside facility. The role focuses on manufacturing documentation, deviations, and change control within a cross-functional team.

You will review batch records, support regulatory inspections, and contribute to process improvements while collaborating with multiple departments to resolve quality issues and ensure product quality

Qualifications

• Bachelor's degree in Biology or Biochemistry preferred.
• Minimum 4 years in pharmaceutical manufacturing QA.
• Solid knowledge of GMPs, SOPs, and quality systems.
• Experience with deviations and change control a plus.

Responsibilities

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

Skills

GMP knowledge

SOP proficiency

Quality systems understanding

Validation principles

Strong communication

Cross-functional collaboration

Computer-based systems

Education

Bachelor's degree in Biology or Biochemistry

Tools

Computer-based systems

Job description

Are you passionate about ensuring the highest quality standards in manufacturing processes? We are seeking a dedicated and technically adept Manufacturing Quality Assurance (MQA) Associate II professional to join our team. In this pivotal role, you will provide critical QA support and oversight to ensure compliance with good business practices and all applicable health authority regulations.

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 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. Relocation benefits are not available for this posting.

Benefits

The expected salary range for this position based on the primary location of California is $67,300 - $124,900 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.