Vertex Manufacturing Center (VMC) manufactures clinical and commercial oral dosage non-sterile pharmaceutical products for human use. RSL is the quality control (QC) lab which provides GMP analytical testing support of incoming, release, and stability samples for developmental, clinical, and commercial starting materials, intermediates, drug substances and drug products manufactured at the VMC. RSL personnel confirms that sample meets the specifications prior to product being delivered to our patients. RSL also manages the manufacturing equipment cleaning verification program, environmental monitoring program, utilities monitoring program and development reference standard program.
Quality Control Scientific Associate II
This role provides a variety of analytical functions that occur in the Release and Stability Laboratory (RSL) 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.
• Perform in-process, release, and stability testing independently following established methodology, procedures, and SOPs
• Maintain accurate testing records and adhere to cGMP/GDP expectations
• May participate in executing method validations and/or method transfers
• Assist in troubleshooting of analytical methods with the assistance of manager when necessary
• Report OOT/OOS results and other deviations to area management.
• Perform other laboratory duties as assigned.
• A minimum of a bachelor’s degree in science or related discipline is required.
• 0-2 years of experience in GMP pharmaceutical/biopharmaceutical industry
• Understand basic cGMP concepts and general practices
• Knowledge and experience in chromatography, dissolution, and/or Karl Fisher
• Attention to detail
• Effective communication skills, both verbal and written.
Apply to This Role:
1. Submit your resume to University_Relations@vrtx.com
2. Title the subject “Quality Control Scientific Associate II”
3. In the body of the email please list the organization you heard about this opportunity through