Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Quality Specialist I. is responsible for supporting the Batch records issuance per applicable process, work order verification for accuracy, manufacturing control card issuance or weighing automated system application and finished good label file creation. Models our 4i values, integrity. Innovation, intensity, and involvement. Complies with our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.

Essential Functions:

Provide On-the-Job training (OJT) as its related to Training in Bartender application to all colleagues.Directly support incoming raw material documentation.Accountable and responsible for the overall material release, and disposition "End to End" (E2E), ensure all investigations related to materials are completed following Quality Systems.Support the quality monitoring and release of all raw materials and products linked to GMP Pilot, Work Order and New Product Introduction.Revise Standard Operating Procedures (SOPs) as needed to support batch record readiness and quality related functions as applicable.Effectively support manufacturing as a QA specialist to properly perform Real Time Batch Record Review and final batch records review and material disposition.Maintain and monitor site compliance with applicable regulations to the site: ISO 9001 or applicable regulatory standard and any transition to any update requirements.Perform all job duties within ISO standards, regulatory or statutory requirements.Performs other duties, projects, as assigned.

Knowledge and Experience

Bachelor’s degree in Life Sciences or Engineering and Minimum 3 – 5 years’ experience in Pharma related / Quality SystemsKnowledge of cGMPs , TrackWise, Laboratory Information Management Systems (LIMS), E1 and Oracle,Knowledge in standards and regulations such as ISO 9001, specifically ISO 9001:2008 and 21 CFR Part 820, 210 or 211.Experience in regulated manufacturing, clean room and gowning requirements.Strong written and oral communication skillsMust be able to communicate effectively with multiple levels of staff throughout the organization.