The QA Specialist reports to the Quality Assurance Manager. This individual works closely with Quality, Operations and Environmental Monitoring personnel to complete assigned tasks for investigations, CAPAs, change controls, on floor audits, training and visual inspection. Responsibilities:· Ability to observe and report on aseptic conditions and technique within clean rooms with a focus on sterility assurance during manufacturing operations· Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.· Write or review assigned investigations, CAPAs and change controls. Verify completed action items associated tasks· Write and revise policies and procedures related to QA functions and activities. Approve procedures requiring QA approval, as assigned· Periodically review records to verify that quality standards for each drug product is met · Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws· Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation· Ensure compliance with approved procedures. Communicate any issues with the appropriate department and support all regulatory and customer quality audits.· Utilize data to analyze opportunities for continuous improvement and prepare reports and metrics· Assist CAPA teams and other project teams in the development of action plans and implementation schedules to meet compliance goals
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· BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field· Minimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.· Ability to effectively communicate in both verbal and written communication forms inter and intra departmentally· Strong technical writing and attention to detail and decision-making ability· Experience with oversight of operations with a strong understanding of aseptic processing· Ability to multi-task and prioritize multiple projects and assignments· Knowledge of QMS, investigation and CAPA related tools or systems is preferred· Experience with regulatory inspections with FDA, USP and/or state pharmacy boards. · Experience with inspection readiness activities preferred· Interpreting and summarizing data for reports, trending and reporting metrics· Computer experience with Microsoft software including: MS Word, Excel, PowerPoint · Flexible and able to adapt to company growth and evolving responsibilities.
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.