Quality Control Analyst

Job Title: Quality Control Analyst Location: Portsmouth, NH 03801 Duration: 12 Months Job Type: Temporary Assignment Work Type: Onsite Pay Rate: $25 to $30 Summary The Quality Control Technical Transfer Analyst 3 is a member of the Quality Control department supporting production through the completion of technical transfer activities. The role also participates in quality testing for customer in-process, final product testing, and stability studies as needed. This position applies job skills and company policies and procedures to complete a variety of tasks of increased scope, working on semi-routine assignments where the ability to recognize deviations from accepted practices and analyze problems of moderate scope is required. 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. 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. Required Skills 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. Ability to comprehend and follow instructions. Ability 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. Ability to complete assignments accurately and on time. Ability to work effectively in a team environment and maintain a positive attitude. Punctuality and reliability in completing assigned work and scheduled shifts. Associate's Degree in Microbiology, Biochemistry, or a related Science field. TekWissen® Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity. #J-18808-Ljbffr