Job Information
Insight Global Quality Specialist in Morris Plains, New Jersey
Job Description
One of our large pharmaceutical clients is looking to hire a Quality Specialist 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 review/approval/implementation 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 required on-site support for quality assurance for oversight of the QC analytical lab.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
-Bachelor degree with a concentration in engineering, science, or an equivalent technical discipline
-Minimum 6-8 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 (QA/QC)
-Experience in biologic or vaccine or cell culture products -Experience with cell and gene therapy products
-Experience with good tissue practices
-Experience in quality operations handling deviations, investigations, OOS, risk assessment/ risk mitigation null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.