Quality Assurance Specialist - Mount Vernon, IN - Global Operations US - Mt. Vernon - IN/en-US/Careers/job/US---Mt-Vernon---IN/Quality-Assurance-Specialist---Mount-Vernon--IN---Global-Operations_R-034826-1/apply At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Were focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Assurance Specialist in Mount Vernon, IN, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing. Careers at AstraZeneca within Global Operations. Take a look at our new Operations Campaign page where you will find details of our roles across our UK, US and SE sites. https://lnkd.in/gf9svGh Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world 20% of our global workforce. With 30 production facilities in 18 countries were focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career thats full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK The Quality Assurance Specialist is responsible for Quality Assurance (QA) activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Responsibilities: * Maintains a high level of understanding of relevant production processes and quality systems. * Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests; - Batch Records and associated documentation; Product and Component Release transactions in SAP; Quality Investigations (Deviations, Product Complaints); Validation Plans, Protocols, and Reports; and Standard Operating Procedures. * Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems. * Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives. * Works with applicable site support groups on projects (capital and non-capital) that impact the * PET/assigned area, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects. * Collaborates with and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices. * Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders. * Collaborates in data analysis and report creation on quality metrics and key performance indicators. * Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance. * Ensures compliance with AZ Corporate Policies and Directives, site Standard Operating Procedures, site policies, work instructions, regulatory requirements, and industry best practice (cGMPs, GAMP, ITIL, PMI). * Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures. * Immediately report potential unsafe conditions to management. * Supports internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections * Participates in the investigation and resolution of product quality problems. Qualifications: Education: * Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or * Bachelors degree with 3 years' experience in pharmaceutical industry in roles covered by GMP oversight. Required: * Excellent oral and written communication skills. * Strong ability and motivation to learn. Next Steps Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Date Posted 30-Aug-2018 Closing Date Posted 4 Days AgoFull timeR-034826 AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. Were inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. Youll be part of a team thats rolling back the frontiers of science to turn yesterdays impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients and in return, well help you develop way beyond what you thought possible.