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Manufacturing Quality Engineer Location: Marietta, PA Length: 6+ months *Rate: * *OPEN hourly* *all inc.* Interview: Phone (F2F preferred) Job Purpose: The QA Operations – Secondary Manufacturing Support Specialist provides a link between Marietta manufacturing operations and the various quality systems. Primary responsibility is to directly support Secondary Manufacturing Operations (formulation, aseptic filling, lyophilization, capping, and inspection) through real-time, on-line batch record QA review and approval. As a member of the Quality Assurance team, be co-responsible for the site and the department results. PRINCIPLE JOB DUTIES: • Perform real time batch record QA review for all aspects of Secondary Manufacturing activities. • Perform final review of room, equipment and associated support systems to release areas for commercial operations. • Review equipment cycle data to ensure proper execution of processes (autoclaves, CIP, SIP). • Provide mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications. • Conduct deviation investigations when assigned, to allow for dispositions of lots, approving return-to-use for quarantine materials, or return-to-service orders for production equipment and facilities following completion of investigations. • Work with operations, maintenance, quality, and engineering teams on quality improvement projects or corrective actions. • Periodic reviews of deviations to identify problem areas in the Marietta facility and recommend corrective actions where appropriate. • Improvements must be value added and focused on improving compliance, quality, customer service, or cost control. • Perform quality reviews and approve maintenance work orders. • Participate in instrument calibration assessments. • Participate in site Operational Excellence initiatives. • Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice. Adhere to all customer safety guidelines and procedures. • Adhere to all Customer Quality Management System (QMS) policies and procedures as applicable for functional area. • Provide QA oversight to MA02 Value Stream through weekly QA meetings with the team regarding Deviations, Change Control, Calibration and Maintenance, CAPAs and SOPs. • Review Operations SOPs and Maintenance SOPs related to Secondary Manufacturing. • Author SOPs as necessary. • Assist with implementation of RIMP for Operations inspection readiness. • Support regulatory and internal audits. • Act as the site Technical Expert for all questions and issues related to Manual Inspection (Filling), Sampling, Re-inspection & Crack Detection to include: o Key contact regarding subjects for other sites and outside contacts, receive the information and distribute to appropriate members of the site. o Become the site leader in the technology – attend conferences, develop technical expertise, conduct onsite training, etc. o Act as the site consultant when issues arise. o Assist with deviations and investigations, lead investigations when appropriate. o Assist with project definition during design of projects including support of IQ/OQ/PQ. o Be site review participant for GSOP development to provide key review output from Marietta to assure the site needs are being addressed and improve our standing with GQA. o Drive continuous improvement. • Work on any assignment as directed. • Ensure personal objectives are aligned with site goals and objectives*.* • Cost: Demonstrate a cost conscience mindset and reduce waste in order to deliver profitability. • Reporting: Ensure that all relevant information relating to all functional responsibilities and activities are tracked, captured and forwarded in due time to the management. • Quality: Ensure all activities are executed following quality and regulatory standards. Promote a quality mindset and quality excellence approach to all activities. • EHS: Ensure all activities are executed including EHS standards and promotes a safety culture. • Act as change agent: Personal responsibility for supporting the value stream way of working at Customer facility in Marietta. • Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, quality systems and FDA regulations. • B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience. • Minimum of 3 years pharmaceutical experience in Quality Assurance preferably in Biologics Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation. • Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. Sareen Bhaskaran Resource Manager Prosoft Cyberworld Group 630-371-0530 ext 145 sar...@prosoftcyberworld.com YAHOO IM: sareen_prosoftcyberworld PLEASE MARK A CC TO recruitersar...@gmail.com --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Powerbuilder Assignments" group. 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