Quality Control Analyst II/III - Analytical (Nights)

Lonza - Portsmouth, NH

Full-time - Mid Level

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

The Quality Control (QC) Analyst II/III (Night Shift) will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. A QC Analyst III: Applies job skills and company's policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

Responsibilities

• Running test samples for In-Process, Lot Release and Stability studies.
• Reviewing assays.
• Training others.
• Writing Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects - such as method transfers, new instruments, method qualifications.
• Perform other duties as assigned.

Requirements

• Bachelor's or Associate's Degree. Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
• 2-5+ years industry experience, preferably in a cGMP environment.
• Use of Microsoft Suites (Word, Excel, Powerpoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
• Excellent ability to speak publicly.
• Excellent ability to interpret data.
• Perform assigned, complex and/or varied tasks. Make basic quality decisions independently.
• Begin to mentor other analysts.
• Prioritization and problem solving.
• Comprehend and follow instructions. Be able to communicate instructions to others in a clear, concise manner.
• Direct, control and plan tasks/projects.
• Brainstorming.
• Excellent ability to communicate in both written and verbal format.
• Relate to others in a team setting.
• Maintain positive attitude in a team environment.
• Act as an example of professionalism to other Level 1 and 2 analysts.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving and departure on time.