Operational Area Senior Quality Specialist (Contract) 29503

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 position reports directly to the Director of GMP Operational Quality, Compliance and Technical Operations

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Reviews and approves investigations, CAPA’s and change controls

• Acts as Quality Owner for deviations, including review and approval of associated CAPA, and coordinates with Manufacturing Technical Ops (MTO) to ensure assignment within QA team for minor quality events.
• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls as Quality
• Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations.
• Ensures appropriate CAPA actions are identified and addressed.
• Communicates proactively with internal partners and management.
• Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.

Minimum qualifications:

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

$55-$65/hr

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

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at

privacyadministrator@atriumstaff.com

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

tempstaffing@vrtx.com

No C2C or Third-Party Vendors