One of our large pharmaceutical clients is looking to hire a QA Associate to join their growing External Quality team within Advanced Therapeutics. This individual will be providing Quality support for site and process qualification activities, engineering runs, and commercial product manufacturing. Main responsibilities will include:
-Remote quality support for production activities, including deviation and CPA review, escalation of critical issues, batch review and release and change control.
-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 Janssen team lead
Required Skills & Experience
-Bachelor's degree with a concentration in engineering, science, or an equivalent technical discipline
-Minimum of 10 years working in pharmaceutical aseptic manufacturing operations and quality assurance
-Experience with facility and equipment qualification and validation
-Previous tech transfer experience
-Detailed knowledge of cGMPs related to pharmaceutical production
-Strong interpersonal and written/oral communication skills
-Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment
Nice to Have Skills & Experience
-Experience in Good Tissue Practices
-Experience in biologic or vaccine or cell culture products