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.
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
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.
...we are People Strong, Innovation Driven. Headquartered in Lynchburg, Virginia, BWXT is a Defense News Top 100 manufacturing and engineering innovator that provides safe and effective nuclear solutions for global security, clean energy, environmental restoration, nuclear...
...Blize healthcare is looking for an Intake Coordinator/Office Assistant to join our team. Intake Coordinator Job Requirements: Completing insurance forms and answering any patient inquiries. Scheduling home health/hospice visits efficiently. Handling daily patient...
Job requirements:1. It is best for white Americans to have a good image and temperament2. Have a spirit of teamwork3. Strong camera sense and strong sense of family4. Provide worksPart time salary interview Job Responsibilities:1. Participate in the shooting of family...
...cardiology, cardiothoracic and vascular surgery, diabetes and endocrinology, gastroenterology, surgery, gynecologic oncology, infectious disease, maternal fetal medicine, occupational health, oncology, hematology, orthopedic surgery, palliative care, pediatric critical...
YOUR IMPACT We are seeking a VP-level candidate to join the Global Risk Management team within Goldman Sachs Asset Management. We are looking for an individual who has a strong expertise within risk management, including market risk and liquidity risk, who can...