What are the responsibilities and job description for the Quality & Compliance Specialist position at Vertex Pharmaceuticals?
Job Description
General Summary:
The Quality Assurance Specialist understands the principles and application of quality assurance and compliance. The Quality Assurance Specialist coordinates Quality Systems activities in support of drug product and combination medical devices for cell & genetic therapies programs. This role is primarily located in Providence, RI with occasional travel into Boston, MA. The Quality Assurance Specialist reports to the Quality Systems Manager.
Key Duties and Responsibilities:
- Provide quality support to operations at the VCGT facilities in the following key areas/activities: document control, training, quality systems such as change control, deviation, and CAPA.
- Participates in cross-functional teams to develop, implement, and improve processes
- Provides guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.
- Works collaboratively with the global quality systems team to ensure sites remain in compliance with the global requirements
- Coordinates training activities for various departments within a GxP environment
- Assists in developing processes to support the organization’s records management system, including assisting in the transition from paper-based to an electronic document and records management system
- Responsible for coordinating the training staff on use of the electronic document management system
- Assists quality record owners with ensuring compliance to SOP requirements.
- Responsible for identifying risks and communicating any gaps for quality processes optimization
- Participates in inspection readiness and support activities
Knowledge and Skills:
- Experience providing QA support to GMP manufacturing operation
- Medical device/Cell & Gene experience preferred.
- Experience with network-based applications such as Oracle, TrackWise, Veeva
- Understanding of regulatory environment including quality systems and compliance.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Some experience successfully participating in event investigations, Root Cause Analysis and CAPA
- Strong communication and influencing skills
- Critical Thinking / Problem Solving skills
Education and Experience:
- Bachelor's degree in relevant field is required
- 1 years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid- or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
2. On-Site work 5 days per week with ad hoc flexibility.
#LI-ND1 #LI-Hybrid
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.