Specialist III, Quality Assurance Operations - LSA

Lonza; Portsmouth (NH); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player in life sciences is seeking a Specialist III in Quality Assurance Operations. This pivotal role ensures compliance with GMP standards while supporting manufacturing operations. You will be part of a dynamic team focused on maintaining high-quality standards and driving continuous improvement. With a commitment to ethical practices, the company empowers its employees to make a significant impact on global health. If you are passionate about quality assurance and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• 5-7 years of GMP experience, including 3-5 years in Quality Assurance.
• Knowledge of cGMP regulations and compliance.

Responsibilities

• Review and approve GMP documents and batch records.
• Conduct QA walkthroughs and collaborate with manufacturing teams.
• Support QA activities on the production floor.

Skills

GMP Compliance

Quality Assurance

Technical Skills

Planning and Organization

Cross-Department Collaboration

Adaptability

Education

Bachelor's Degree in a Scientific Field

Tools

Trackwise

SAP

Document Management Systems

Job description

Job Title: Specialist III, Quality Assurance Operations - LSA

Located in New Hampshire, Lonza is a global leader in life sciences, operating across five continents. We believe our greatest strength is our talented people working together to develop ideas that help businesses and improve lives. We offer our employees the opportunity to own their careers and contribute to meaningful work that makes a difference in the world.

We are seeking a Specialist III, Quality Assurance Operations - LSA to ensure our quality requirements are met with precision. This role involves supporting manufacturing operations, maintaining high standards, and ensuring strict adherence to cGMP compliance. You will be part of a collaborative team dedicated to excellence in our processes.

Key Responsibilities:

• Review and approve GMP documents such as master batch records, SOPs, work instructions, and completed documents.
• Review and approve completed batch records, QC documents, and electronic records related to batches.
• Conduct QA walkthroughs and collaborate with manufacturing and support teams to resolve issues.
• Support QA activities on the production floor.
• Cross-train with team members to serve as a backup for document control functions.
• Perform project-related tasks as assigned.
• Perform other duties as required.

Key Requirements:

• Bachelor’s Degree or equivalent in a scientific-related field.
• 5-7 years of GMP experience, including 3-5 years in Quality Assurance, preferably in biotechnology manufacturing.
• Knowledge of cGMP regulations and compliance.
• Flexibility to adapt to changing priorities.
• Ability to work effectively across departments and with clients.
• Strong technical skills related to GMP operations.
• Effective planning, organization, and control skills.
• Ability to prioritize and work under pressure to meet deadlines.
• Understanding of continuous improvement within GMP standards.
• Experience with Trackwise, SAP, and document management systems is preferred.

At Lonza, we are committed to ethical practices, respecting our people and environment. We believe that our success is measured not only by results but also by how we achieve them.

Join us to solve complex problems, develop innovative ideas, and make a positive impact worldwide. We are an equal opportunity employer and welcome applicants regardless of race, religion, gender, age, disability, veteran status, or other protected characteristics.