2nd Shift - Quality Control Sr. Associate/Sr. Specialist (contract) 843

Atrium Works • Boston, MA

15d • Onsite

About The Position

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. This role 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. The shift for this position is 2nd shift (12:30pm - 11:00pm est.) Wednesday - Saturday. Training will be Monday-Thursday 11am-9:30pm for the first 60-90 days. The candidate should have extensive experience working with flow cytometry.

Requirements

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

Nice To Haves

• Extensive experience working with flow cytometry.

Responsibilities

• Performs typical test methods including, but 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.
• Troubleshoots analytical methods and participates in Quality Events (Deviations, OOS).

Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level