Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsibility for daily operation of laboratory including coordination of testing and data review to meet due dates. Participates in continuous improvements, lean activities, kaizens and other process improvement initiatives. Performs Quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products. Requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers. Receives a minimal level of guidance and direction and proactively seeks advice/information from others when addressing serious business issues that may impact other functions. Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals. Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory. Speaks up on tough issues and occasionally challenges the status quo. Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas. Effectively balances own point of view with new information and the perspectives of others while addressing conflict among peers and/or team members. Works to develop new skills and abilities. Readily accepts performance feedback and incorporates this feedback into future performance. Assists other team members, including helping with developmental activities. Learns to use new problem-solving tools to surface and solve issues. Excellent organizational and time management skills. Assists in direction of plant wide or departmental objectives. Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory. Ability to interpret our Company Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements, including current Good Manufacturing Practice (cGMP), New Drug Application (NDA), and related regulations, and can interpret those regulations for implementation in the workplace. Possesses an expanded knowledge of theories, practices and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing and change control principals, solid technical writing capabilities with demonstrated ability to perform more complex investigations, procedural updates, audit responses, equipment qualification and development of validation protocols, etc.