Quality Inspector, QC, IQC, QA

Quality InspectorThe Quality Inspector role is to support manufacturing quality. Responsible for timely and effective GMP review of production records in order to maintain a continuous flow of records, and to manage and control materials used for the product realization including nonconforming materials. Responsible for Lot release testing.Job DescriptionMaintain the effectiveness of Quality Management Systems to assure compliance with GMP: Manufacturing site Policies and Procedures ISO 13485 QMS, 21 CFR 820 QSR Relevant global quality systems. Participates in the implementation of the Quality Management System. Perform manufacturing QC processes in a timely manner including lot release testing and testing related to validation, qualification. Calibration and maintenance of laboratory equipment and related systems, maintenance of laboratory equipment. Assist in the development of QC/QA procedures, Protocols, reports, create and maintain QC/QA documentation for new and existing products, processes, and equipment. Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial related products for accuracy and compliance within procedures and GxP requirements. Monitors stability studies of developmental, clinical, and commercial related products tested internal or contract laboratories. Analyze and evaluate preliminary testing data, initiate NCMR and other quality related tasks as appropriate. Assist supervisor/manager in maintaining the current laboratory and QC/QA activities. Contact point for instrumentation issues and providing training and troubleshooting support to the laboratory on new or existing instrumentation. Monitor and ensure compliance of all laboratory equipment and associated systems and provide training to technicians as required. Prepare, review & approve laboratory documentation related to laboratory instrumentation and systems (e.g. SOPs, validation protocols, reports etc.) Provide support to laboratory investigations involving laboratory systems including NCMR and deviation Work with cross functional teams on new product transfer, qualification, validation, etc. Reviews, enters, and maintains stability data for developmental, clinical, and commercial products. Transfers analytical methods and qualification as applicable. Prepares and maintains QC/QA documentation, including protocols, reports, and test methods. Procures reference materials for contract analytical laboratories. Maintains and updates department documents required for regulatory compliance and assures testing requirements adherence to latest regulatory standards. Engage in managing the documentation Change Control Process including receiving / generating, identifying, distributing, tracking, and publishing Change Requests and Orders as applicable. Engage in filing, identification, archiving, storage, recovery and destruction of QC/QA Documentation and Records as needed. Review & Release of WIP Materials and Finished Goods for GMP this includes review of quality records for: Good Documentation Practices/Data Integrity Completeness of records Accuracy of records Lot/part/description accuracy Materials and Finished Goods included, but not limited to: Wafers HPC Preparation, and performing a variety of routine and QC/QA tasks following cGMP regulations Work collaboratively with required functions as part of a cross functional team to investigate customer complaints and address them in a timely manner. Work collaboratively with cross functional teams as relevant and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner.QualificationsRequired Knowledge of GMP (21 CFR Part 820, and ISO 13485) Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point Sound knowledge of cGMP and experience in a regulated industry Strong verbal and written communication skills Excellent organizational skills along with strong attention to detail Education / Experience HS degree is preferable or equivalent 2-3 years of experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) with Quality Assurance role Experience with developing/documenting procedures/work instructions Familiar with a variety of the field's concepts, practices, and procedures Working knowledge of computerized quality systems (i.e. QMS, LIMS) is a plus Demonstrated change management experience, guiding the organization to the desired state Preferred Experience with Electronic Systems for handling complaints, investigations, CAPAs, Calibrations, Electronic Batch records, control of documents etc. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative.