Qc Analyst Level Iv - Environmental Monitoring (days)

Lonza Group

Portsmouth, NH, USA
Not specified; not specified; medical, dental, vis...
Onsite (day shift, monday – friday, 8:00 am – 5:00 pm)
Bachelor's degree in life sciences
5-10 years cgmp experience
Environmental monitoring expertise
Lonza Group is seeking a QC Analyst IV for Environmental Monitoring in Portsmouth, NH. The role involves leading technical initiatives, ensuring compliance with regulatory standards, and mentoring junior analysts in a dynamic biotech environment

Job Summary

  • This senior role serves as a Subject Matter Expert leading the Environmental Monitoring team to maintain microbial control strategies.
  • The incumbent is responsible for leading complex investigations, utilizing root cause analysis tools, and implementing effective CAPAs.
  • Candidates will represent the EM program during internal and external regulatory inspections by agencies such as the FDA and EMA.

Matching Summary

Match Score: 85

Lonza Group is seeking a QC Analyst IV for Environmental Monitoring in Portsmouth, NH. The role involves leading technical initiatives, ensuring compliance with regulatory standards, and mentoring junior analysts in a dynamic biotech environment.

Salary

Not specified; Not specified; Medical, dental, vision, 401(k), and performance-based incentives included

Skills & Requirements

Must-have

  • Bachelor's degree in Life Sciences
  • 5-10 years cGMP experience
  • Environmental Monitoring expertise
  • Root cause analysis tools
  • Cleanroom classification knowledge

Nice-to-have

  • Lean Laboratory initiatives
  • Rapid microbiological methods
  • Cross-functional leadership
  • Paperless data systems
  • Advanced technical writing

Key Requirements

  • BS in Microbiology or Biology required
  • 5-10 years QC Microbiology experience
  • cGMP manufacturing environment background
  • Expertise in Annex 1 and global regulations

Work Rights

Not specified

Tailored Resume

Cover Letter