Senior Quality Assurance Engineer (HIT)
The Position At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world. This position is part of Genentech's Pharma Technical - Hillsboro Individualized Therapies (HIT) team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology. As a member of the Quality System and Qualifications team you will be supporting the design and start up of a GMP facility capable of high throughput manufacturing and analysis, you will help define the requirements for Quality Systems, Qualification and Validation and will establish processes that will enable the organization to operate successfully. This role provides the opportunity to closely partner with other clinical facilities, PTD and Global Quality teams as you work on start-up activities like establishing and implementing the Quality Systems and Validation strategies for next generation production. The new Quality System will enable high volume, specialized manufacturing and rapid testing in support of instantaneous disposition while in full compliance with cGMP.
Responsibilities:
Technical and Functional:
Provide Quality Oversight to projects focused on the design, development and qualification of equipment into GMP manufacturing as well as laboratory areas Ensure procedures for Qualification and Support Process reflect current GMP requirements Ensure that operational and laboratory areas are qualified to meet current GMP requirements Ensure rapid resolution of issues, including discrepancies, investigations, and implementation of effective CAPA (corrective actions preventive actions) Maintain the compliance status of the assigned qualification areas at a state of inspection readiness. Working with multiple functions, lead solution of qualification and data integrity issues following cGMP regulations and Genentech standards. Site Quality technical and regulatory subject matter expert for qualifications and regulatory requirements. Create an engaging work environment while maintaining high flexibility and agility within and across teams and functions Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements. Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning Support the implementation of automated QC methods Present qualification program studies to regulatory agency inspectors. Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Support the user requirements and design for production and laboratory equipment and systems Review and approve qualification documents (e.g. Qualification Master Plans, Project Plans, User Requirements, Protocols, Qualification Deviations, Summary Reports, etc) for cGMP and technical content. Provide technical and quality qualification assessment and approval for engineering and process changes. Collaborate with departments to ensure qualification activities are executed compliantly, with efficiency and effectiveness Participate in the risk stages of procuring new equipment. Collaborate with departments to ensure risk management and qualification activities are executed efficiently and effectively. Present and provide rationale for the qualification program and execution during audits and regulatory inspections. Establish team priorities to meet overall project targets and timelines; manage competing priorities for the overall good of the project Serve as an HIT QEV representative on cross-functional and multi-site teams Lead or participate in the design and implementation of department and cross-functional initiatives Apply advanced theory, technical principles, and expert judgment to address a broad range of technical and organizational problems Perform any other tasks as requested by management to support project milestones and product launch Qualifications/Requirements:
B.S. /B.A. degree plus 8-11 years of experience or Master's degree plus 6-9 years of experience for Senior QA Specialist. B.S./B.A. degree (preferably in Chemistry, Biochemistry, or relevant scientific discipline) plus 5-7 years of experience or Master's degree plus 3-5 years of experience for QA Specialist III. Experience is in pharmaceutical or biopharmaceutical industry Laboratory design and start-up experience is preferred Sound knowledge of cGMPs or equivalent regulations Knowledge in the design, build, and deploy phases for both automation and execution systems (Delta V/SCADA, Syncade, MES, BAS, EBR, Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment Sound knowledge in Qualification Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA). Professional level written and oral communication skills, ability to organize and present information informal and formal group setting Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures Ability to make sound decisions about allocation of resources and managing priorities Flexibility in problem solving, providing direction and work hours to meet business objectives Ability to troubleshoot instrumentation Work Environment/Physical Demands/Safety Considerations Work in office and laboratory environment Lift up to 25 lbs may be required Ability to sit, stand and move within work space for extended periods May be required to sit at a computer terminal for extended periods Ability to travel up to 30% to other sites as required
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Technical and Functional:
Provide Quality Oversight to projects focused on the design, development and qualification of equipment into GMP manufacturing as well as laboratory areas Ensure procedures for Qualification and Support Process reflect current GMP requirements Ensure that operational and laboratory areas are qualified to meet current GMP requirements Ensure rapid resolution of issues, including discrepancies, investigations, and implementation of effective CAPA (corrective actions preventive actions) Maintain the compliance status of the assigned qualification areas at a state of inspection readiness. Working with multiple functions, lead solution of qualification and data integrity issues following cGMP regulations and Genentech standards. Site Quality technical and regulatory subject matter expert for qualifications and regulatory requirements. Create an engaging work environment while maintaining high flexibility and agility within and across teams and functions Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements. Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning Support the implementation of automated QC methods Present qualification program studies to regulatory agency inspectors. Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Support the user requirements and design for production and laboratory equipment and systems Review and approve qualification documents (e.g. Qualification Master Plans, Project Plans, User Requirements, Protocols, Qualification Deviations, Summary Reports, etc) for cGMP and technical content. Provide technical and quality qualification assessment and approval for engineering and process changes. Collaborate with departments to ensure qualification activities are executed compliantly, with efficiency and effectiveness Participate in the risk stages of procuring new equipment. Collaborate with departments to ensure risk management and qualification activities are executed efficiently and effectively. Present and provide rationale for the qualification program and execution during audits and regulatory inspections. Establish team priorities to meet overall project targets and timelines; manage competing priorities for the overall good of the project Serve as an HIT QEV representative on cross-functional and multi-site teams Lead or participate in the design and implementation of department and cross-functional initiatives Apply advanced theory, technical principles, and expert judgment to address a broad range of technical and organizational problems Perform any other tasks as requested by management to support project milestones and product launch Qualifications/Requirements:
B.S. /B.A. degree plus 8-11 years of experience or Master's degree plus 6-9 years of experience for Senior QA Specialist. B.S./B.A. degree (preferably in Chemistry, Biochemistry, or relevant scientific discipline) plus 5-7 years of experience or Master's degree plus 3-5 years of experience for QA Specialist III. Experience is in pharmaceutical or biopharmaceutical industry Laboratory design and start-up experience is preferred Sound knowledge of cGMPs or equivalent regulations Knowledge in the design, build, and deploy phases for both automation and execution systems (Delta V/SCADA, Syncade, MES, BAS, EBR, Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment Sound knowledge in Qualification Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA). Professional level written and oral communication skills, ability to organize and present information informal and formal group setting Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures Ability to make sound decisions about allocation of resources and managing priorities Flexibility in problem solving, providing direction and work hours to meet business objectives Ability to troubleshoot instrumentation Work Environment/Physical Demands/Safety Considerations Work in office and laboratory environment Lift up to 25 lbs may be required Ability to sit, stand and move within work space for extended periods May be required to sit at a computer terminal for extended periods Ability to travel up to 30% to other sites as required
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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