Quality Oversight Analyst (2nd Shift)
Site Name: USA - Nebraska - Lincoln Posted Date: Sep 22 2021 Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this Quality Oversight Analyst role could be an ideal opportunity to explore. As a Quality Oversight Analyst, you will be the first line of contact for operational quality advice and support for Production and other site areas as we strive for early detection to help prevent potential quality issues. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Provides Quality Oversight for the production areas including Manufacturing, Packaging, Warehouse and Laboratories by performing process confirmations Review GMP related documentation such as SOPs, Change Controls, Deviation and Technical Reports. Approves any changes associated with these documents. Assists the site to move to a proactive approach of incident prevention from a reactive approach of incident assessment and management Supports continuous capability development of self and others to improve processes Support/Perform audits and Inspection Readiness efforts making sure that area logbook and documentation is accurate and reviewed in a timely manner Support product release team including review of batch tickets and resolution of issues in a timely manner Facilitate, coach and mentor teams and individuals to build site capability in the RCA and CAPA processes Provides guidance in Excellence in Deviation Management and Human Factors Analysis tools and techniques along with coaching on Root Cause Analysis and other quality tools during an investigation Work across multiple value streams to drive continuous improvement and promote quality culture. Utilizes and continuously improves the GPS standards (i.e. 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree with specialization in a Technical or Scientific discipline Minimum 3 years experience in a similar role or equivalent combination of education and experience. Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11. Knowledge and application of the principles of Quality management Systems (QMS) Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level. Ability to work well under high pressure and deadlines Flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes GSK Values, Behaviors and Strategies. Excellent verbal and written communication skills. Conflict resolution and interaction management skills. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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