2nd shift - GMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649
$135,200–$145,600 year
On-siteBoston, Massachusetts, United States
Job Summary
Oversee floor quality oversight for autologous cell and gene therapy production within controlled cGMP cleanrooms, ensuring compliance with policies, procedures, and regulations. Support batch records review and disposition, including source data review, while collaborating with site personnel to resolve quality issues and determine immediate paths forward. Execute root-cause analysis for deviations, OOS, and OOT investigations to identify appropriate CAPA actions, and collect data to report on metrics. Author SOPs, train employees on processes, and represent Vertex Quality on cross-functional teams to drive continuous improvement and assist with regulatory agency inspections.
Required Qualifications
- Sunday to Wednesday, second shift (12:30PM to 11 PM EST)
- Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
- Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines
- Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
- Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
- Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences
- Able to integrates activities with other groups, departments and project teams as needed
- Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
- Excellent team player and collaborator
- Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
- Bachelor's degree in scientific or allied health field (or equivalent degree)
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