GxP Operations Support Specialist Data Review

Job Description

General Summary:

The GxP Operations Support Specialist 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:

• Perform in-process, release, and stability testing and/or review 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
• May participates in author and review of data, SOPs, analytical methods, protocols and reports
• May participate in compliance related teams working towards the goal of continuous improvement.
• Report OOT/OOS results and other deviations to area management.
• Perform other laboratory duties as assigned.

Knowledge and Skills:

• Understands cGMP concepts and general practices
• Knowledge and experience in chromatography, dissolution, and Karl Fisher
• Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
• Strong attention to detail
• Demonstrate good communication skills both oral and written.

Education and Experience:

• Bachelor Degree in science or related discipline is required
• 1 year of experience in GMP pharmaceutical/biopharmaceutical industry

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$38 - $57

Disclosure Statement:

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]