GMP Operational Quality Senior Specialist (QA Ops for QC)

Job Description

General Summary:

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. This role 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.

Key Duties and Responsibilities:

• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Supports change control assessments, implementation and closure
• Identifies and facilitates continuous improvement efforts
• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects
• 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 approval of data
• Support the day-to-day management of the batch release process
• 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 findings to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GxP operational areas.

Knowledge and Skills:

• Experience supporting multiple projects/teams within stated objectives and timelines
• Experience supporting cross-functional team members and collaborate effectively
• Good communication skills (written and verbal) and the ability to exchange potentially complex information
• Able to integrates activities with other groups, departments and project teams as needed
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience:

• Bachelor's degree in scientific or allied health field (or equivalent degree)
• Typically requires 2+ years of experience, or the equivalent combination of education and experience

Required Knowledge/Skills:

• Strong communication and influencing skills
• Critical Thinking/Problem Solving
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Proficiency in using Microsoft Office applications
• Some experience with Cell and/or Gene Therapy QA experience, working knowledge of aseptic processing and quality metrics, dashboards, analysis and improvement programs
• Some experience providing QA support and oversight of GMP manufacturing operation
• Some experience successfully participating in event investigations, Root Cause Analysis and CAPA
• Some experience with network-based applications such as Oracle, TrackWise, Veeva
• Basic knowledge of current industry trends and has the ability to use the latest technologies

#LI-onsite

Pay Range:

Disclosure Statement:

Flex Designation:

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 ApplicationAssistance@vrtx.com