QA Specialist II - Raw Materials Quality & Compliance

Lonza Biologics, Inc.; Portsmouth (VA); On-site; Confidential; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, and vision insurance

Career growth opportunities

Agile work culture

Training and development

Job summary

Lonza Biologics, Inc. is seeking a QA Specialist II for Raw Materials Compliance to ensure quality and compliance of raw materials used in life-changing therapies. You will partner with Quality, Supply Chain, Logistics, MSAT, and other stakeholders to maintain uninterrupted operations while driving continuous improvement.

The role emphasizes GDP compliance, documentation review, and issue resolution. The ideal candidate has 5+ years in quality within regulated environments, with strong cGMP/GDP

Qualifications

• Bachelor's degree in science or engineering or related field.
• Minimum 5 years of quality experience in a regulated industry.
• Strong knowledge of cGMP, GDP, and quality system requirements.
• Experience reviewing technical documentation, specifications, certificates, and quality records.
• Strong attention to detail, organizational skills, and documentation review capabilities.
• Proven problem-solving skills with the ability to identify quality risks and improvement opportunities.
• Effective communication, collaboration, and stakeholder management skills in a regulated environment.

Responsibilities

• Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results.
• Review supplier and manufacturer documentation to ensure accuracy, completeness, and compliance with approved requirements.
• Provide guidance on GDP compliance, material receipt and disposition activities, inventory controls, and quality documentation practices.
• Partner with QA, QC, Supply Chain, Logistics, and MSAT teams to resolve material-related issues and support timely material availability.
• Support investigations, deviations, and quality events by providing expertise in raw material quality and compliance requirements.
• Identify quality risks and process improvement opportunities while helping implement sustainable compliance solutions.
• Develop and deliver training while providing support and guidance on raw material quality requirements to cross-functional stakeholders.

Skills

Quality compliance

cGMP & GDP knowledge

Documentation review

Quality risk identification

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in science or engineering

Job description

Lonza Biologics, Inc. is seeking a QA Specialist II for Raw Materials Compliance to ensure quality and compliance of raw materials used in life-changing therapies. You will partner with Quality, Supply Chain, Logistics, MSAT, and other stakeholders to maintain uninterrupted operations while driving continuous improvement.

The role emphasizes GDP compliance, documentation review, and issue resolution. The ideal candidate has 5+ years in quality within regulated environments, with strong cGMP/GDP