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Lonza

Global life sciences contract manufacturer

Quality Control Analyst II

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeFrederick, MD, USAIn-person

About the Job

Requirements

  • Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience preferred; relevant GMP laboratory experience may be considered in lieu of formal education
  • Minimum of 3 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment
  • Experience supporting GMP stability programs, including sample management, testing coordination, inventory tracking, and documentation activities preferred
  • Working knowledge of analytical laboratory techniques, aseptic practices, and GMP laboratory operations
  • Familiarity with GMP regulations, data integrity principles, quality systems, and laboratory compliance requirements
  • Experience supporting laboratory investigations, including deviations, out-of-specification (OOS) results, CAPAs, or other quality events
  • Strong analytical, organizational, troubleshooting, and problem-solving skills, with the ability to effectively manage multiple priorities
  • Strong written and verbal communication skills, with the ability to work collaboratively across teams and maintain accurate laboratory documentation

Responsibilities

  • Perform routine and moderately complex testing of in-process, release, environmental, and stability samples with minimal supervision
  • Review, analyze, and interpret laboratory data to ensure accurate, complete, and timely reporting of results
  • Support GMP stability programs, including stability protocol execution, sample inventory management, testing coordination, and documentation review
  • Participate in laboratory investigations, including deviations, out-of-specification (OOS), and atypical results, identifying root causes and supporting corrective actions
  • Author, revise, and maintain SOPs, test methods, protocols, reports, and other GMP documentation
  • Train and support laboratory personnel on analytical techniques, procedures, and best practices
  • Assist with method transfers, validation activities, equipment qualification efforts, and continuous improvement projects
  • Support day-to-day laboratory operations, including sample management, inventory control, equipment maintenance, and external laboratory coordination

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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