Quality Assurance Specialist II

Summary The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist II primarily works in the cGMP areas to manage adherence to the quality system and assist in and/or initiate the resolution of deviations. The role Represent company Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented. Review quality control testing for compliance with internal SOPs and specifications. Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations. Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc. Perform and/or participate in internal audits, external audits, investigations, and/or inspections. With supervision, may respond or manage responses to clients regarding manufacturing, testing and/or documentation issues. May develop and/or maintain Quality System metrics for management review. Provide on the floor support to operations, including coordinating and performing day to day activities as needed. May assist in developing and conducting training of personnel to execute production in full accordance with cGMP’s and quality systems to ensure real-time compliance. May perform QA visual inspection activities when required. Participate in regulatory and client audits. Other duties as assigned. Requirements BA/BS Degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry OR MA/MS Degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry. Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211. #J-18808-Ljbffr Hartmann Young