Quality Control Senior Specialist

Responsibilities

• Execute and support analytical method technical transfers, qualifications, and validations both internally and externally.
• Utilize techniques including flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assays.
• Deliver essential documentation such as SOPs, qualification/validation protocols, and reports.
• Support QC investigations regarding assay-related issues, Out-of-Specification (OOS) results, change controls, and deviations/CAPAs.
• Lead data trending, invalid reporting, and continuous improvement initiatives.
• Support the generation and qualification of assay controls, standards, and critical reagents.

Requirements

• Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or a related science.
• 2-5 years of experience in the pharmaceutical or biopharmaceutical industry.
• Proven experience in analytical Quality Control, method development, or method transfer/validation.
• Strong technical knowledge of flow cytometry, cell-based assays, qPCR, and ELISA.
• Proficiency in MS Office and statistical analysis software such as GraphPad or JMP.
• Excellent technical writing and communication skills.

Preferred Qualifications

• Experience specifically within cell-based therapy.
• Familiarity with project management tools.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• 401(k) with company matching.
• Commuting subsidies and charitable donation matching.

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to advancing clinical and research programs for conditions such as cystic fibrosis, sickle cell disease, and type 1 diabetes.