QA Specialist II - Site Compliance
Roche - Oceanside, CA

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Responsible for providing comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable Health Authorities. Supports Site Compliance functions in association with the manufacturing, testing, disposition and distribution of Bulk Drug Substance. Ensures that Oceanside product(s) consistently meets our customer and regulatory requirements. Support regulatory inspection and audit activities Influence and implement initiatives to improve overall compliance and maintain inspection readiness Lead proactive compliance risk identification and mitigation and maintain site Quality Compliance Scorecard. Follow-up on corrective and preventative actions to ensure implementation, compliance and continuing efficacy. Compile metrics and provide reporting Support department to meet corporate goals and department objectives Train staff as needed Support regulatory applications Collaborate with internal departments and external partners to manage project expectations, schedules and deliverables. Write and maintain QA SOPs as required. Collaborate with other departments to address issues and meet deadlines Participate in and/or lead project teams as a Quality representative Collaborate with other departments to address issues and meet deadlines All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). Ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt. BS/BA in Life Science (Biology or Biochemistry) or Equivalent Minimum 6 years pharmaceutical experience Minimum 4 years experience in Quality Assurance. Knowledge, Skills, and Abilities Audit or inspection experience preferred. Excellent communication skills, verbal and written. Strong knowledge of Good Manufacturing Practices, Standard Operating Procedures, Quality Systems, and general compliance principles. Knowledge of cGMP regulations applicable to the U.S.A. and international regulatory agencies. Demonstrated ability to manage multiple activities while maintaining a high level of organization. Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision. Familiarity with project management and continuous improvement principles. Able to work effectively in a customer service and business partner role. Ability to anticipate problems before they become critical and involve management when appropriate. Ability to work as part of a team and collaborate effectively with staff at all levels. Ability to work independently in achieving goals and objectives. Work Environment/Physical Demands/Safety Considerations Works in office environment. On occasion may work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment. May be exposed to hazardous materials and chemicals.
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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...