Job Description

General Summary:

The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

***This role is 2nd Shift from 3 pm to 11 pm Wednesday - Saturday ***

Key Duties and Responsibilities:

• Reviews master batch records and provides customer approval for quality tasks for externally manufactured products

• Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures

• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.

• Reviews and approves investigations, CAPA’s and change controls for external programs

• Support the day to day management of the batch release process.

• Support annual product quality reviews

• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.

• Communicates proactively with internal and external partners and management.

• Maintains files such that documents are readily available and easily retrievable.

• Assists department with monthly/quarterly Quality System data review metrics and reporting

• Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.

Education and Experience:

• Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience

• Experience providing QA support and oversight of GMP manufacturing operation

• Experience successfully leading event investigations, Root Cause Analysis and CAPA

• Experience with network-based applications such as Oracle, Veeva

• Knowledge of current industry trends and ability to use the latest technologies

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

#LI-Onsite #ND-2

Flex Designation:

Flex Eligibility Status:

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 ApplicationAssistance@vrtx.com