Leads GLIMS projectĭrives Deviation Reduction through trending and proactive identification of improvement initiatives. Requires little to no supervisionĭrives continuous improvement and supports sustainability of implemented changes identified through such lean tools or champions new actions as a result of data obtained through lean methodology. Has the ability to effectively manage multiple and changing priorities/projects and ensure timely completion. Explains difficult issues and works to build alignment around a complex situation. Ability to independently respond to advanced requests for data and trending of data from multiple systems and sources and proactively utilizes trending of data to improve the operation or drive change. Solves complex problems and takes a new perspective on existing solutions. Possesses an advanced knowledge and ability to operate information systems required to complete job responsibilities with the ability to view data and build reports from these systems in standard and non-standard requests. Possesses advanced technical writing capabilities and is able compile complex investigations, procedures, justifications, qualifications/validation protocols, agency responses, etc. Possesses an advanced knowledge of theories, practices, and procedures in the Quality Control Laboratory discipline, including the knowledge and understanding of pharmaceutical operations systems. Understands and applies regulatory / compliance requirements. Ability to interpret our Company Quality Policies and Guidelines for daily application. Functions as a subject matter expert on cGMPs and regulatory requirements, as well as plant and divisional processes. Assists in direction of plant wide or department objectives.Īpplies knowledge of information / external business challenges to provide input into recommendations for improvement to processes and products. Good organizational and time management skills. Demonstrates capability as a visionary for on-going continuous improvement. Demonstrates routine use of analytical tools to solve issues and simplify processes. Assists other team members, including helping with developmental activities. Pays close attention to the work of others and proactively steps in to help as needed. Relentlessly pursues new opportunities to learn new skills and abilities and acquire new knowledge. Does not hesitate to deal with difficult conflict among peers and/or team members. Responds to challenges non-defensively, effectively balancing one’s point of view with new information new information. Challenges the status quo and pushes others forward constructively. Consistently takes the customer point of view when examining implications of systems, process or workflow changes. Demonstrates a deep understanding of customer needs, requirements, and expectations and is sought out by peers as the expert. Drives the use of team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals. Carefully weighs priorities, costs, and benefits when determining risks. Promotes teamwork and open discussion of issues. May act as a team or project lead and mentors’ others, as required. Builds knowledge of the company, processes, and customers. Solves complex problems and takes a new perspective using existing solutions. Acts as a resource for colleagues with less experience within own discipline. Works independently with minimal guidance. Requires expertise in the Quality Control Laboratory discipline and applies knowledge of internal/external business challenges to improve products and processes. Leads GLIMS projects, participates in Quality Audits, proficient in GCM, MIDAS, EMPOWER and SAP in support of the laboratory, provides technical support initiatives to keep the laboratory in compliance with global regulations and our Company guidelines. 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. 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.

Glims pharm