GMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649-1
About The Position
The Quality Shop Floor Specialist is responsible for the floor quality oversight of the production of autologous cell and gene therapy product in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance per policy, procedures, and regulations. The role will also be responsible for supporting batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Specialist coordinates or executes activities on a wide range of projects and plays a role in the design and execution of new projects. This is a Sunday to Wednesday, first shift (7:00 AM to 5:30 PM EST) role.
Requirements
- 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)
Responsibilities
- Support manufacturing activities for cGMP compliance and collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
- Support shop floor check and audit trail review.
- Collaborate with business partners to resolve quality issues to ensure compliant solutions
- Support root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Collect data and report on metrics
- Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
- Support continuous improvement projects
- Author SOP's to support commercial quality functions.
- Assist with regulatory agency inspections
- Identify and support continuous improvement efforts
- Train employees and provide insights and education on processes and procedures.
- Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
- Gown into cleanrooms and controlled environments
Benefits
- medical benefits
- fringe benefits
- overtime pay
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What This Job Offers
Job Type
Full-time
Career Level
Senior
