Quality Control Analyst

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

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.
• 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.

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.