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Lonza

Global life sciences contract manufacturer

Quality Assurance Specialist - Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTampa, FL, USA

About the Job

Requirements

  • A bachelor's degree in a Science or related field, or equivalent experience.
  • Proficient experience in quality assurance or manufacturing.
  • Knowledge of pharmaceutical current Good Manufacturing Practice (cGMP) standards.
  • Familiarity with Quality Management Systems such as Trackwise and SAP, and with Microsoft Office tools.
  • Experience in audits and regulatory compliance processes is advantageous.

Responsibilities

  • Review standard operating procedures (SOPs), batch records, test methods, protocols, deviations, corrective and preventive actions (CAPA), and related documentation to ensure compliance with cGMP standards.
  • Approve SOPs, Master Batch Records, executed batch records, and laboratory data reports.
  • Assess product quality impact for open deviations during lot release.
  • Participate in investigations and internal, vendor, and customer audits, and provide support during regulatory inspections.
  • Collaborate with cross-functional teams to resolve issues and achieve departmental goals.
  • Attend client meetings and calls to support quality initiatives.
  • Ensure adherence to safety and sustainability requirements, reporting and correcting issues promptly.

Desired Qualifications

  • Experience in audits and regulatory compliance processes.

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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