QA Batch Release Assistant (Fri-Sun 6a-6p)

Who We AreFagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.About The JobThe Batch Release Assistant will perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.Key ResponsibilitiesReviews all batch documentation for accuracy and completeness according to cGMP’s to ensure timely release of batches. Execute batch record review and review of supporting systems, to include LUMAC reviewAdheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation. Ensures all GMP’s, Work Procedures and SOP’s are followed. Identify exceptions and report exceptions to production. Ensures deviations are initiated for any batch record review related events Find/communicate deviations to appropriate department for investigation. Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release. Addresses deficiencies and ensures timely completion of all follow-up actions for resolution to all batch review issues according to GMP standards. Responsible for final batch disposition based on review of all associated documentation. Assist in resolving quality problems/concerns related to batch review Work proactively on a daily basis to ensure schedules are maintained and material is readily available. Build quality into all aspect of the material release process by maintaining compliance to all quality requirements Basic QualificationsHigh School Diploma or EquivalentExcellent verbal and written communication skillsProficient in Microsoft OfficeProficient in Microsoft OutlookCollege credits in biology, chemistry, or science related courses is preferredExperience in manufacturing is preferredKnowledge of good documentation practices is preferredWhat's on Offer?We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.Ready for the challenge?Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.