IIC

About IIC

Title: Quality Specialist II Location: Miami, Florida 33169 Duration: 06+ Months Job Description: Summary of Responsibilities 1.1.1.The Quality Specialist II, is responsible for supporting manufacturing operations by performing quality monitoring, real time batch record review, performing material disposition for Components, Raw Materials, Semi-Finished and Finished products for powder and liquid product family using the Material Management System and ERP. 1.1.2.Initiate and conduct investigations to determine Quality impact, using the Material Management System and ERP. 1.1.3.Issue batch records for Manufacturing and packaging activities. 1.1.4.Manage the labeling system process, support Internal and Customer Audit program. 1.1.5 Supporting documentation management system and document revision, creation. 2. Duties & responsibilities 2.1.The Quality Specialist II, is responsible for supporting manufacturing operations by performing Quality Monitoring which includes daily rounds to the manufacturing areas. 2.2.Responsible for supporting Quality by Design activities linked to production operations: Real Time Batch Record 2.3.Perform material disposition for Raw Materials, Semi-Finished and Finished products for powder and liquid product family using the Material Management System and ERP. 2.4.Review Quality Control Laboratory Data for completion accuracy and perform material disposition accordingly using the Material Management System and ERP 2.5.Initiate and conduct investigations to determine Quality impact, using the Material Management System (ERP). Quality Event Notifications and Planned Deviations using (TrackWIse). 2.6.Review and Complete packaging component release using the Material Management System and ERP. 2.7.Manage the labelling system process which encompass Master Label System Maintenance, Label Changes and Label Issuance and Control. 2.8.Issue batch records for Manufacturing and packaging activities. 2.9.Support Audit Program: Conducting and tracking Internal and Customer Audits 2.10.Assist Quality Manager in plant process improvement activities and implementation of Quality Systems. 2.11.Serves as a back for the management of the Stability program and Reserve samples. 2.12. Revision of documents and work instructions 2.13. Supporting the Documentation management system Training system and support data entry Management of paper-based documentation records: creation, filing and retention. Perform administration duties of the Document Control and Change Order activities in accordance with GMP and quality standards. Maintains and coordinates documentation as required by the manufacturing facility such as Batch Records, Log Books, Calibration Records, and other documentation activities as required. Maintains, controls, verifies, and ensures change orders are processed using Quality Documentation Management Systems or another electronic system is accurate and in a timely manner. Responsible for supporting Master Data Activities for New Product Activation and Evaluating Master Data impact. Manage the administration of the Document Retention program. Design, develop and writing Standard Operating Procedures (SOPs) as needed to support custom and P2P Manage the labelling system process which encompasses Master Label System Maintenance, Label Changes and Label Issuance and Control. Provides quality support to Advanced Bioprocessing Miami projects and future Advanced Bioprocessing projects. Performs other duties, projects, as assigned. Ensure Compliance as System Administrator of the Learning Management System Maintain training records for associates in accordance with Corporate and Site Quality Policies. Collect and record training in learning system for instructor-led, On-Job-Training, and other 3rd party training for plant associates. Maintain E-Signature files. Develop training requirements for associates with department supervisors. Support updates to associate training requirements for new procedures and add to the appropriate curricula. Create training items following governance rules. Create scheduled course offerings in upon request. Provide technical support for the Learning Management System to Advanced Bioprocessing Miami associates. Provide training compliance reports to functional site leadership on a monthly basis. Manage data collection of plant level data for materials within the site for all materials type. Manage and ensure compliance of the assigned Quality systems: Learning Management Systems, Documentation Management System. 3.Position requirements 3.1.Qualification 3.1.1.Extensive knowledge in Microsoft Office tools, Documentum, Material Management System (ERP) or similar Electronic Material Management Systems. 3.1.2.Thorough knowledge of FDA / ISO regulations, particularly as they relate to Manufacturing, Packaging, Quality Control Laboratory, Documentation Control and the ability to navigate in networked systems. 3.1.3. Knowledgeable in Documentation Management Systems, technical writing of investigations and Visio application. 3.2.Education 3.2.1.Bachelor’s degree with demonstrated proficiency/knowledge in software applications (Material Management Systems (ERP) Investigations Systems (Track Wise), and Good Manufacturing Practices (GMP). 3.2.2.Basic knowledge of scientific terms, concepts and acronyms useful. 3.2.3.Ability to learn, apply and train others in new systems.. 4.Desired experience 4.1.Two (2) years in working with Material Management Systems (ERP) and Computer application. 4.2.Two (2) years’ experience with computer applications directly supporting Quality Systems (ERP system, Track Wise or equivalent). 4.3.Two (2) years of Pharmaceutical or Medical Device experience required. 4.4.One Year experience in of technical writing required 5.WORKING CONDITIONS 5.1.Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources. 5.2.Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required. 5.3.Exposure to high frequency noise. 5.4.Ability to lift up to 25 pounds repetitively, and up to 65 pounds non-repetitively. Job Type: Contract Contract Length: 1 year

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