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.
#CSLI - SJ# 1025651