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Job Description

General Summary:

The Quality Control Senior Associate role provides a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

Key Duties and Responsibilities:

• Performs Quality Control (QC) testing of Cell Therapy in-process, release and stability samples. Typical test methods performed include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), gram stain and endotoxin (LAL) testing.
• Performs technical reviews of raw data.
• Records test results and maintains raw data and accurate laboratory records.
• Performs general lab and equipment maintenance duties.
• Performs other duties as assigned.
• Occasional weekend, holiday and after-hours work (5- 10% of the total time)

Knowledge and Skills:

• Performs tasks with strict adherence to cGMP and cGDP principles.

• Has an understanding of basic laboratory equipment and practices.

• Is proficient in the use of spreadsheets and word processing software.

• Is dependable and able to work well within a team.

• Is interested in learning new things. Open to change.

• Is optimistic and displays a positive attitude even during periods of adversity.

• Shows initiative; acts independently with management approval.

• Possesses a high attention to detail.

  Education and Experience:

• A minimum of a Bachelor Degree in science or related discipline is required.
• Requires less than 1 year of experience in GMP pharmaceutical/biopharmaceutical industry

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