Job Description
Job Description:
We are seeking a Quality Control Technical Transfer Analyst 3 to join our Quality Control team. This role supports production by contributing to technical transfer activities and ensuring high-quality testing for in-process materials, final products, and stability studies. The ideal candidate is detail-oriented, highly organized, and experienced in laboratory testing and documentation within a regulated environment.
Key Responsibilities
- Perform testing for In-Process, Lot Release, and Stability studies.
- Conduct testing for investigations, transfers, and validations.
- Review assay results and ensure data integrity compliance.
- Write and manage Quality Records (Deviations, CAPA, Change Control) and Test Methods.
- Support method transfers, new instrument implementation, and method qualifications.
- Train team members on quality control processes and laboratory techniques.
- Utilize Microsoft Office Suite (Word, Excel, PowerPoint) and laboratory computer systems.
- Work within GMP Quality Systems such as TrackWise and LIMS.
- Identify deviations from standard procedures and escalate as needed.
- Apply Data Integrity principles and ensure compliance with company policies.
- Participate in problem-solving, prioritization, and project planning efforts.
- Maintain a positive and team-oriented attitude, contributing to a collaborative work environment.
Requirements:
- Associate’s Degree (or higher) in Microbiology, Biochemistry, or a related scientific field.
- Experience in a GMP-regulated laboratory or manufacturing environment is preferred.
- Strong public speaking and communication skills (both verbal and written).
- Ability to interpret data independently or with guidance.
- Strong problem-solving skills and ability to prioritize tasks effectively.
- Proficiency in quality systems, laboratory software, and data integrity principles.
- Self-motivated team player with a commitment to accuracy and quality.
- Ability to work full assigned shifts, including timely arrival and task completion.