Quality Control Analyst II - Environmental Monitoring (Night Shift)

Lonza•Portsmouth, NH

1d•Onsite

About The Position

QC Analyst II – Environmental & Microbial Control (Night Shift) Location: Portsmouth, NH, USA. As a QC Analyst II, you are a critical guardian of our manufacturing environment. Working on the front lines of our night shift operations, you will perform the essential testing—including environmental, utility, and product sampling—that ensures our facility remains in a state of control. This role is designed for an experienced analyst who can recognize deviations from accepted practice and provide high-quality results to meet rigorous manufacturing demands. Shift Information We are seeking dedicated professionals for our Night Shift (8:00 PM – 6:30 AM). This is a 4-day, 10-hour schedule (40 hours per week). Note: The specific shift pattern (e.g., Sunday–Wednesday or Wednesday–Saturday) will be determined by the business based on current team needs. Night and weekend shifts include a competitive pay differential. What You’ll Get Technical Ownership: Work on assignments of moderate scope that require analysis of identifiable factors and sound scientific judgment. Impactful Responsibility: Your data directly supports the release of drug lots for global customers. Collaborative Night Team: Join a focused, self-motivated team that relies on clear communication and mutual support. Comprehensive Benefits: Medical, dental, vision, 401(k), and performance-based incentives. Our full list of global benefits: lonza.com/careers/benefits. What You’ll Do Microbial & Environmental Monitoring: Execute routine HVAC and Utility sampling throughout the facility to ensure the manufacturing environment meets strict cGMP standards. Analytical Testing: Run test samples for In-Process, Lot Release, and ongoing customer Stability studies. Data Integrity & Review: Apply rigorous Data Integrity (DI) principles in all aspects of your work. You will review assays and laboratory records for accuracy and compliance with Lonza policies. Deviation Recognition: Work on semi-routine assignments where you must recognize and escalate any deviations from accepted practices or results. System Mastery: Utilize Microsoft Office Suite and specialized Laboratory Information Management Systems (LIMS) to document and track results in real-time. Judgment & Action: Exercise judgment within defined procedures to determine appropriate actions when troubleshooting technical variances.

Requirements

Experience: 2–4 years of experience in a Quality Control Laboratory or a regulated cGMP manufacturing environment is required.
Education: Associate’s degree in Microbiology, Biochemistry, or a related Science field is required. A Bachelor’s degree is preferred.
Analytical Capabilities: Strong ability to interpret complex data both independently and with guidance.
Proven ability to prioritize and solve problems in a fast-paced environment.
Effective communication skills (written and verbal) for shift handovers and technical reporting.
Attributes: A self-motivated team player who maintains a positive attitude and demonstrates a high level of commitment to quality and timeliness.

Nice To Haves

A Bachelor’s degree is preferred. (A combination of education and equivalent experience will be considered)

Responsibilities

Microbial & Environmental Monitoring: Execute routine HVAC and Utility sampling throughout the facility to ensure the manufacturing environment meets strict cGMP standards.
Analytical Testing: Run test samples for In-Process, Lot Release, and ongoing customer Stability studies.
Data Integrity & Review: Apply rigorous Data Integrity (DI) principles in all aspects of your work. You will review assays and laboratory records for accuracy and compliance with Lonza policies.
Deviation Recognition: Work on semi-routine assignments where you must recognize and escalate any deviations from accepted practices or results.
System Mastery: Utilize Microsoft Office Suite and specialized Laboratory Information Management Systems (LIMS) to document and track results in real-time.
Judgment & Action: Exercise judgment within defined procedures to determine appropriate actions when troubleshooting technical variances.