Job Description

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.

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