Lonza

Quality Assurance Specialist (QC)

Posted Apr 22, 2025
Job ID: R67023
Location
Vacaville, CA
Hours/week
40 hrs/week
Payrate range
Unknown

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:

  • 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.

We recognize that attracting, developing, and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this position is $105,000 and $167,000. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including 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.

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