Quality Assurance

Quality Assurance SpecialistThis position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.Essential Duties and ResponsibilitiesAchieve and maintain packaging line and inspection room clearance qualificationConduct accurate verifications and checks as well as accurate process inspectionsConduct accurate packaging AQL inspectionsIdentify out of specification product, ensuring segregation and escalation, as requiredEnsure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirementsEnsure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.Conduct component and raw material releaseConduct chart monitoring, ensuring escalation, as requiredSupport product shipping activities and perform quality related oversight and verificationsGenerate logbooks and sheets/labelsReview Bills of MaterialsBasic knowledge of cGMPs and supporting regulatory documentsAchieve and maintain clean side gown and sterile side gown qualificationsAchieve and maintain Class A qualificationPerform room, area and equipment clearances.Participate in Media Fill and maintain qualificationAble to perform tasks with minimal error rate.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsHigh School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.Must be able to do work independently.Intermediate skills in Microsoft Word and Excel are required.Excellent organizational, interpersonal and communication skills (written and oral) required.Ability to take feedback constructively and function in a team oriented work environment.Ability to work overtime as needed.Physical Environment and RequirementsPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.Employee must be able to occasionally lift and/or move up to 25 pounds.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.