Quality Control Analyst

Responsibilities

• Support production by contributing to the completion of technical transfer activities.
• Perform quality testing for in-process, lot release, final product testing, and stability studies.
• Run test samples for investigations, method transfers, and validations.
• Review assays.
• Train others.
• Participate in projects including method transfers, new instrument implementation, and method qualifications.
• Write quality records, including Deviations, CAPAs, Change Controls, and Test Methods.
• Apply Data Integrity principles in compliance with Lonza policies, guidelines, and procedures.
• Perform software validation activities, including writing GMP procedures, validation documents, and executing test scripts.
• Act as a Subject Matter Expert (SME) for at least one software system.
• Communicate with cross-functional teams to interpret needs and priorities.
• Perform technical root-cause analysis for software errors.
• Remain current on all assigned training activities.
• Perform other duties as assigned.

Requirements

• Experience with Change Control, Deviations, CAPAs, Tasks, EICRs, and Investigations.
• Experience writing Quality Records (Deviations, CAPAs, Change Controls) and Test Methods.
• Experience using Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience using laboratory computer systems.
• Experience with GMP quality systems such as TrackWise and LIMS.
• Experience with software including SoftMax Pro, Empower, and SoloVPE.
• Experience with software validation, including writing GMP procedures, validation documents, and executing test scripts.
• GMP experience within the pharmaceutical industry.
• Ability to recognize deviations from accepted practices.
• Ability to analyze data and problems of moderate scope.
• Strong ability to interpret data independently and with guidance.
• Strong verbal and written communication skills, including public speaking.
• Prioritization and problem-solving skills.
• Able to comprehend and follow instructions.
• Able to direct, control, and plan tasks and projects.
• Brainstorming and analytical skills.
• Exercises judgment within defined procedures and practices.
• Self-motivated team player with a commitment to quality.
• Able to complete assignments accurately and on time.
• Able to work effectively in a team environment and maintain a positive attitude.
• Punctuality and reliability in completing assigned work and scheduled shifts.

Qualifications

• Associate's Degree in Microbiology, Biochemistry, or a related Science field.

Skills

• Change Control
• Deviations
• CAPAs
• Tasks
• EICRs
• Investigations
• Quality Records
• Microsoft Office Suite
• Laboratory Computer Systems
• GMP Quality Systems
• TrackWise
• LIMS
• Software Validation
• SoftMax Pro
• Empower
• SoloVPE
• Microbiology
• Biochemistry
• Related Science Field

Benefits

N/A

Pay

$25 to $30

Schedule

N/A