GMP Operational Quality, Senior Specialist (Contract) 25048

The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives. The GMP Operational Sr. Quality Specialist Contractor is recognized as a subject matter expert in the principles and application of quality assurance and compliance. The Sr. Quality Specialist Contractor coordinates GMP activities in support of commercial disposition. This position reports directly to the Senior Manager, GMP Operational Quality.

The ideal candidate will have experience providing Quality Support of GMP manufacturing operations (batch release), experience with small molecule (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting and knowledge of cGMP requirements governing small molecule manufacturing

Key Responsibilities:

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Vertex or at contracted suppliers
• Enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Supports change control assessments, implementation, approval, and closure
• Supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. 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.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Maintains Quality Metrics to support on time release deliverables
• Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports
• Identify and communicate risks and assist with risk mitigation plans as necessary
• 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

Minimum qualifications:

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 integrate 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 3 years of experience, or the equivalent combination of education and experience
• Experience providing Quality support and oversight of GMP manufacturing operation including batch release
• Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
• Knowledge of cGMP requirements governing oral drug products manufacturing practices

$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. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors