Quality Assurance Specialist

Compensation & Notes:Fully onsite position Mon-Fri in Morris Plains, NJ$50-$56hr- Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave andor other paid time off as provided by applicable law.Qualifications:Bachelor's degree with a concentration in engineering, science, or an equivalent technical discipline Minimum 5+ years of experience working within drug substance or pharma manufacturing space Minimum 4-6 years of experience working with analytical methods i.e. flow cytometry within QC manufacturing space Solid quality-centric experience and mindset (QAQC) -Strong interpersonal skills both written and verbal Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environmentExperience in biologic or vaccine or cell culture productsPrevious experience working with or for CMOs is requiredJob Description: One of our large pharmaceutical clients is looking to hire a Quality Person In Plant to join the growing External Quality team within Advanced Therapeutics. This individual will be providing Quality oversight of the analytical space. Main responsibilities will include: -Review and approve nonconformances and deviations out of specification. -Interface as liaison internally and externally for reviewapprovalimplementation of change controls. -Support monitoring of EM quality performance and proactively identify risks. -Influence and build relationship with internal and external partners to continuously enhance quality performance. -Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer -Apply cGMP regulations and other FDA and international requirements to all aspects of the position. -Provide on-site support as needed on request of the team lead

Created: 2024-11-06