Operational Area Quality Senior Specialist (Contract)
About this role
Job Description
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 individual is primarily responsible for coordinating the delivery of Annual Product Quality Review (APQR) and Quarterly Product Quality trending.
This position reports directly to the Director of Quality Systems.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
- Coordinates with SMEs to develop the scope and author content of APQRs.
- Ensures appropriate CAPA actions are identified.
- Ensures completed reports are approved and archived.
- Assist with executing and developing quarterly product quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations.
- Assist with preparation of Quality Management Review materials.
- Identifies and facilitates continuous improvement efforts.
- Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
- Support continuous improvement projects.
Required education level:
- Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.
Required experience:
- Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
- Experience with network-based applications such as Veeva.
- Knowledge of current industry trends and ability to use the latest technologies.
Required knowledge/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.
Contract Length: 12 months with the chance to extend.
Pay Range
$61/hr. - $69/hr.
Shift/Hours
Monday–Friday, hybrid role: three days in the office, two days at home.
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Company at a glance
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and has made significant advancements in cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain — and continues to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.
Our global headquarters is in Boston, and we have research and development (R&D) sites and commercial offices worldwide.
Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards.
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