Quality Assurance Specialist

Are you passionate about ensuring the highest quality standards in manufacturing processes? We are seeking a dedicated and technically adept Quality Assurance Specialist 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.

This position requires on-site presence, and is a Mon-Fri schedule.

The Opportunity:

As a QA Specialist, 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, provide technical support as and build productive working relationships within the company. Your responsibilities will include providing project support in a quality capacity, managing deviations, provide technical support as Environmental QA (EQA), and ensuring our facilities and operational systems align with approved SOPs and cGMP standards. Additionally, you will:

• Collaborate with multiple departments to resolve GMP issues during manufacturing processes and ensure compliance with governing policies such as return to service, product changeover, and facility release activities.

• Provide QA oversight of cleaning, facility, and environmental monitoring (EM) programs, including regulatory inspection support and routine assessments of room classifications and monitoring locations to ensure consistency.

• Oversee deviations by working with deviation owners, ensuring closure requirements are met, assessing product quality impact, and recommending material dispositions consistent with Roche and regulatory standards.

• Design, implement, and manage the EM program to align with company policies, track performance metrics, and identify continuous improvement opportunities.

• Review facility operations, critical utilities, and support systems to ensure compliance with cGMP, SOPs, and regulatory requirements, while recommending corrective actions where required.

• Write, revise, and approve SOPs and changes associated with Change Control processes, ensuring clear communication and adherence to company standards.

• Integrate environmental health, safety, and security into business processes while fostering a safety culture, reporting incidents, and addressing quality or regulatory issues promptly.

Who you are

• You possess a Bachelor's degree (Biology or Biochemistry preferred) and 5 or more years of relevant experience or an equivalent combination of education and experience

• You possess a minimum of 4 years 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 not available for this posting.

The expected salary range for this position based on the primary location of California is $77,490 (min) - $110,700 (mid) - $143,910 (max). 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 in this link.

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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.