Manufacturing Quality Assurance Associate II

Genentech; Oceanside (CA); On-site; USD 67,000 - 125,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Oceanside, CA, seeks a Manufacturing Quality Assurance (MQA) Associate II to provide QA support ensuring compliance with GMPs and health authority regulations. On-site positions are available Sunday-Wednesday or Wednesday-Saturday, four 10-hour days based on business need.

You will oversee manufacturing documentation, deviations, batch reviews, and change controls, and participate in cross-functional teams to drive process improvements. Relocation benefits available.

Qualifications

• Bachelor's degree in Biology or Biochemistry; 4+ years pharmaceutical industry experience.
• Strong knowledge of GMPs, SOPs, Quality Systems and compliance principles.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

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

Skills

Interpersonal communication

Project management

Computer-based systems

Education

Bachelor's degree in Biology or Biochemistry

Job description

The Position

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.

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.

Relocation benefits are available for this posting.

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.
Benefits

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.