Overview
Quality Assurance Batch Release Assistant – 1st Shift Jobs in Wichita, Kansas, USA at Fagron GmbH & CO. KG
Over de functie
Job Summary:
Quality Assistant will perform 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.
Role Responsibilities:
0-1 years of experience in a pharmaceutical manufacturing environment.
Issues batch records in paper or electronic format and ensures accuracy prior to production.
Issues additional forms and labels as needed.
Reviews batch records in paper format for accuracy and completeness according to SOPs and cGMPs.
Ensures all applicable final quality testing has been completed and is approved.
Identifies deviations from processes and notifies the applicable personnel for the initiation of an investigation.
Identifies, communicates, and tracks errors.
Identifies basic supporting evidence that can supplement a documentation correction.
Assists personnel in completing corrections on their own batches or on other reviewer’s batches.
Dispositions batches based on the document review and result of any applicable investigations.
Familiar with SOPs relevant to batch record review and processes being reviewed.
Wat wij vragen
Profile/Experiences:
High School Diploma or GED
Excellent verbal and written communication skills
Proficient in Microsoft Office and Outlook
College credits in biology, chemistry, or science related courses is preferred
Experience in manufacturing is preferred
Knowledge of good documentation practices is preferred
Wat wij bieden
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
Over het bedrijf
Fagron 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.
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Title: Quality Assurance Batch Release Assistant – 1st Shift
Company: Fagron GmbH & CO. KG
Location: Wichita, Kansas, USA
Category: Quality Assurance – QA/QC, Pharmaceutical
