3rd Shift - Quality Control Sr. Associate​/Sr. Specialist

Job Description

The Vertex Cell and Gene Therapy (C>) Quality Control (QC) team is responsible for the routine testing of samples and associated workflows for our internally manufactured stem-cell based T1D and genetically modified Casgevy programs. C> QC carries out all activities under Good Manufacturing Practices (GMP) guidelines.

The is responsible for supporting 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.

SHIFT - 3rd (9:30pm - 8:00am est.) Wednesday - Saturday

** Candidate should have extensive experience working with flow cytometry **

Key Responsibilities:

• Typical test methods performed include, but are not limited to, flow cytometry, cell counting, cell culture, sterility (BACT), endotoxin (LAL), and Visual Inspection testing.
• Performs technical reviews of raw data.
• Records test results and maintain raw data and accurate laboratory records on paper and in electronic systems.
• Performs general lab and equipment maintenance duties.
• Performs other duties as assigned.
• Troubleshooting analytical methods and participating in Quality Events (Deviations, OOS).

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.
• Experience with electronic lab notebook (LIMS), and demonstrated ability to work with electronic instrument software

Requirements:

• A minimum of a Bachelor's degree in related field of science is required (Biology, Biochemistry, etc).
• Sr. Associate: 2-4 years, Specialist: 4-6, Sr. Specialist 6-8 years of experience in the GMP pharmaceutical/biopharmaceutical industry
• Demonstrated laboratory experience in multiple methodologies listed above

Sr. Associate - $42-52/hr

Specialist - $53-$57/hr

Sr. Specialist - $57-$67/hr