The Quality Control Technical Transfer Analyst 3 is an integral member of the Quality Control team, supporting production by driving the completion of technical transfer activities and contributing to quality testing for in-process, final product testing, and stability studies as needed. This role involves tasks of moderate scope, requiring critical thinking, attention to detail, and adherence to company policies and procedures.
Key Responsibilities:
Perform technical transfer activities and support quality testing for in-process, lot release, and stability studies.
Execute testing for investigations, transfers, and validations.
Review assay results and ensure compliance with established standards.
Prepare and maintain quality records such as deviations, CAPA, change controls, and test methods.
Train team members on laboratory techniques and processes.
Lead or contribute to projects, including method transfers, method qualifications, and implementation of new instruments.
Utilize Microsoft Office Suite (Word, Excel, PowerPoint) and laboratory computer systems effectively.
Apply data integrity principles in all aspects of work, ensuring compliance with applicable policies and procedures.
Troubleshoot and resolve issues, ensuring adherence to GMP quality systems such as TrackWise and LIMS.
Participate in brainstorming sessions and provide actionable insights for improvement.
Adhere to timelines and deliverables, ensuring accuracy and quality in assigned tasks.
Maintain a positive and collaborative team environment.
Qualifications:
Associate's degree in Microbiology, Biochemistry, or a related science field; Bachelor's degree preferred.
Strong public speaking and data interpretation skills, with the ability to work independently and with guidance.
Experience in GMP-regulated environments and familiarity with quality systems such as TrackWise and LIMS.
Proficiency in Microsoft Office applications.
Demonstrated ability to prioritize, problem-solve, and manage tasks effectively.
Strong written and verbal communication skills.
Self-motivated, detail-oriented, and a team player committed to quality.
Proven ability to work on tasks of moderate complexity and recognize deviations from accepted practices.