Overview:
The Quality Control Technical Transfer Analyst 3 plays a key role within the Quality Control department, supporting production and contributing to the successful completion of technical transfer activities. This role also participates in quality testing for customer in-process samples, final product testing, and stability studies as needed. The position requires applying established job skills, company policies, and procedures to perform a variety of semi-routine tasks, while exercising judgment to recognize deviations and resolve moderately complex problems.
Key Responsibilities:
- Support technical transfer activities and contribute to production-related quality control tasks.
- Perform analytical testing on in-process, lot release, and stability study samples.
- Conduct testing for investigations, method transfers, and validations.
- Review and interpret assay results.
- Train other team members on laboratory procedures and practices.
- Author quality records, including Deviations, CAPAs, Change Controls, and Test Methods.
- Lead or support projects involving method transfers, new instruments, and method qualifications.
- Utilize Microsoft Office Suite (Word, Excel, PowerPoint) and laboratory computer systems.
- Work with GMP Quality Systems such as TrackWise and LIMS.
- Apply data integrity principles in compliance with company policies, guidelines, and procedures.
- Perform other duties as assigned to support department and organizational goals.
Qualifications:
- Associate's Degree in Microbiology, Biochemistry, or a related scientific discipline.
- Experience with analytical techniques such as A280, CE-SDS, icIEF, ELISA, SoloVPE, and qPCR preferred.
- Strong ability to interpret data independently and collaboratively.
- Skilled in public speaking, written, and verbal communication.
- Proven ability to prioritize, problem-solve, and manage tasks/projects effectively.
- Experience authoring technical documentation and quality records.
- Familiarity with GMP quality systems and laboratory best practices.
- Demonstrated ability to work in a team setting with a positive and collaborative attitude.
- Self-motivated with a commitment to delivering high-quality, timely results.
Core Competencies:
- Strong organizational and time management skills.
- Sound judgment within established guidelines.
- Ability to brainstorm, collaborate, and lead initiatives.
- Consistently displays accountability, accuracy, and quality focus.