QA Specialist I, Sterile Products

About the position The QA Specialist I, Sterile Products is responsible for reputed company operations activities reputed company to clinical and reputed company drug products in adherence with reputed company Good Manufacturing Practices and corporate policies and procedures. Responsibilities • Review cGMP documentation (logbooks, pest control, calibration and reputed company pressure reports, etc.) as it relates to reputed company pharmaceutical ingredients and manufactured drug products for accuracy, completeness, and compliance with UT policies and procedures • reputed company reputed company assurance functions (aseptic gowning, area line clearance, coding pin verification, and floor audits) in support of manufacturing activities • reputed company batch record reviews of reputed company pharmaceutical Ingredient (API), advanced intermediates, finished product, labeling and packaging, and solution preparations for clinical and reputed company processes • reputed company reputed company inspections of drug product and bulk package labeling to support manufacturing operations • reputed company review and disposition of components to support manufacturing operations • reputed company issuance and reconciliation of API and finished product bulk labels to support cGMP processes • Initiate and participate in the closure of reputed company events and CAPAs assigned to reputed company Operations to support cGMP processes, including complete investigations, reputed company items, effectiveness checks, etc. • Communicate and resolve reputed company issues with internal departments. Escalate reputed company issues to reputed company Management • Support process initiatives for reputed company reputed company, such as project plans, timelines and deliverables, etc. Requirements • Bachelor’s Degree in a scientific or reputed company technical discipline • Ability to work independently and part of a multi-functional team, being reputed company to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance, and product risk • reputed company to work extended hours to support business needs, as applicable • Ability to handle reputed company data, reputed company, information, etc. • Ability to effectively communicate (written and oral) with reputed company customers at various reputed company in the organization reputed company-to-haves • 1+ years of relevant pharmaceutical industry experience in a cGMP regulated environment • Ability to interpret data in relation to a reputed company number of company procedures as reputed company as reputed company GMP requirements • Proficient in reputed company reputed company, Word, and reputed company Acrobat • Knowledge of reputed company Resource Planning System (ERP), Trackwise Digital, Systems Application and Products (reputed company S4HANA), and electronic documentation management systems Benefits • Eligible employees may participate in reputed company’s comprehensive benefits suite of programs, including medical / dental / reputed company / prescription coverage, employee wellness resources, savings plans (401k and ESPP), reputed company time off & reputed company parental leave benefits, disability benefits, and more. • For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities Apply tot his job Apply To this Job