Quality Assurance Specialist (QC)
Apply NowCompany: Lonza America Inc
Location: Vacaville, CA 95687
Description:
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Job Description:
This position performs Quality oversight of Facilities and Engineering, Process Engineering, Process Automation, Validation and Quality Control. The quality oversight responsibilities include the system qualification lifecycle, and product and process lifecycle activities, such as equipment, facilities, and utilities qualification, process automation qualification, process validation, cleaning validation, sterilization validation, computerized system validation, and shipping qualification.
Key Responsibilities:
Key Requirements:
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
The full-time base annual salary for this position is expected to range between $105,000 and $167,000. Compensation for the role will depend on a number of factors, including the successful candidate's qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Job Description:
This position performs Quality oversight of Facilities and Engineering, Process Engineering, Process Automation, Validation and Quality Control. The quality oversight responsibilities include the system qualification lifecycle, and product and process lifecycle activities, such as equipment, facilities, and utilities qualification, process automation qualification, process validation, cleaning validation, sterilization validation, computerized system validation, and shipping qualification.
Key Responsibilities:
- Ensure GMP requirements are met for qualification and validation of manufacturing equipment/systems, quality control equipment/systems, buildings, utilities, computerized systems and manufacturing processes.
- Review and approve qualification and validation documents.
- Qualification and validation expert for systems and projects.
- Participate in local change management process as change assessor and/or change owner
- Professional review and, if necessary, approval of SOPs and other GMP relevant documents in the respective area of responsibility.
- Facilitate RCA to identify cause of deviations.
- Work with system owners, engineers, and Validation to design, build, and test new systems to ensure the systems reliably meet their intended use.
- Partner with the Validation and Qualification departments to ensure validation/qualification testing is performed effectively and efficiently.
- Ensure the execution of validation/qualification testing meets cGMP regulations and Lonza standards.
- Partner with maintenance and technical groups to ensure the maintenance program meets process requirements and equipment is reliably maintained.
- Apply advanced theory, technical principles, and expert judgement to address a broad range of difficult problems.
- Assess impact to the qualified state of equipment related to discrepancies for qualification relevant topics.
- Provide input to revised and new policies and procedures to effectively guide validation/qualification efforts.
- Solve a wide range of difficult validation/qualification, calibration and maintenance issues that impact multiple functions in alignment with cGMP regulations and Lonza standards.
- Assess the impact of changes to the qualified state of equipment during the operate and maintain phase.
Key Requirements:
- Bachelor's degree in life sciences, engineering, or relevant field.
- At least 7 years of quality oversight experience in the biopharmaceutical manufacturing industry is required.
- Experience with regulations (US, EU and other).
- Experience in managing complex business setups and projects.
- Experience working in multiple quality areas within the pharmaceutical industry.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
The full-time base annual salary for this position is expected to range between $105,000 and $167,000. Compensation for the role will depend on a number of factors, including the successful candidate's qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.