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Quality Senior Specialist (Contract) LOOKING FOR Quality Senior Specialist (Contract) JOB AT Boston, MA
Job Description
General Summary
The Operational Area Quality Specialist works with a high degree of independence to provide QA Analytical support for release and stability program for commercial and clinical products. This role will review analytical data, deviations, change controls, and other quality systems documentation in support of product disposition and stability.
Key Responsibilities:
- Reviews of analytical data for release and stability of Commercial and Clinical products including DS, DPI, DP and packaged goods. Reviews of analytical data associated to method validation and tech transfer activities
- Generates and approve Certificate of Analysis
- Supports Analytical Investigations, and Quality Events: Deviations, OOS Investigations, CAPA and change controls assessments. Leverage technical and compliance expertise to for root-cause analysis and product impact assessment.
- Maintains files such that documents are readily available and easily retrievable.
- Communicates proactively and collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions.
- Assist with qualification of CMOs/CTLs for reduced review certification.
- Manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
- Support continuous improvement efforts as assigned.
Education and Experience:
- Bachelor’s degree in a scientific discipling, chemistry, engineering, or allied health field and 3+ years of relevant work experience, or comparable background.
- Experience within QA/QC is preferred
- Experience with supporting stability program is preferred.
- Experience with supporting Analytical Investigations, OOS’s and OOT’s is preferred.
- Strong attention to detail.
- Self-motivated, independent, organized, and an effective communicator.
- Has the ability to navigate a fast-paced work environment.
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
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 [email protected].