Specialist III, Quality Assurance Operations - LSA

Lonza Biologics Porriño SLU; Portsmouth (NH); On-site; USD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Specialist III in Quality Assurance Operations, where your expertise will help maintain high standards in manufacturing. This role is crucial for ensuring compliance with cGMP regulations and supporting various departments to achieve flawless production processes. You'll have the opportunity to work in a collaborative environment, tackling complex challenges and making a meaningful impact on people's lives. If you're ready to contribute to a team dedicated to excellence and continuous improvement, this position is perfect for you.

Qualifications

• 5-7 years of experience in a GMP environment.
• Minimum of 3-5 years in Quality Assurance or similar field.

Responsibilities

• Review and approve GMP documents and completed batch records.
• Perform QA walkthroughs and resolve issues with manufacturing.

Skills

Quality Assurance

GMP Compliance

Project Management

Document Control

Continuous Improvement

Inter-departmental Collaboration

Education

Bachelor’s Degree in Scientific-related Field

Tools

Trackwise

SAP

Document Management Systems

Job description

Specialist III, Quality Assurance Operations - LSA

United States, Portsmouth (New Hampshire)

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.

Are you ready to join a world-class team and contribute to Lonza's adventurous growth? We are seeking a Specialist III, Quality Assurance Operations - LSA to ensure our quality requirements are met detailed! Located in beautiful New Hampshire, you’ll be part of a collaborative team dedicated to maintaining outstandingly high standards in our manufacturing operations! This role offers the outstanding opportunity to support various departments and ensure that our production processes are flawless and strictly adhere to cGMP compliance.

Key responsibilities:

• Review and approve GMP documents like master batch records, SOPs, work instructions, and completed documents.
• Review and approve completed batch records, QC documents, and electronic records associated with a batch.
• Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
• Support activities that involve QA presence on the floor.
• Cross-train with other members of the Document Control Team to serve as a backup for other functions, such as issuing documents and handling review and approval workflows.
• Perform project-related tasks as assigned.
• Perform other duties as assigned.

Key requirements:

• Bachelor’s Degree or equivalent experience, preferably in a scientific-related field.
• 5-7 years of experience in a GMP environment with a minimum of 3-5 years in Quality Assurance or a similar field. Biotechnology manufacturing background is preferred.
• Knowledge of cGMP and regulations.
• Demonstrates flexibility to adapt to changing business priorities.
• Ability to work inter-departmentally and with customers.
• High level of suite-specific operations and technical skills.
• Demonstrate ability for effective planning, organizing, and controlling proficiency.
• Able to prioritize effectively and achieve results.
• Good ability to complete assignments under timelines and work under pressure.
• Demonstrates knowledge on continuous improvement within the adherence to standardized procedures & cGMP compliance.
• Experience with Trackwise, SAP, and Document management systems preferred.

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.

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.