Supervisor, QC (Chemistry) Method Transfer

Accountabilities

• Exhibits Cardinal Health's high ethical standards and code of conduct.
• Applies expertise to improve effectiveness and solves standard and non-standard problems, providing guidance to employees.
• Sets priorities for technology transfer team to ensure task completion, coordinates work activities with other shifts/teams (1st/2nd/Weekend).
• Assists team in the achievement of goals/commitments, achieving own goals/commitments regardless of obstacles.
• Has in-depth knowledge of work processes and tools within own area and can function as a subject matter expert (SME).
• Partners with leadership to make decisions, often difficult and/or unpopular, that impact the work of subordinates within job family; influences subordinates to support decision by presenting rationale/business case.
• Role models Cardinal Health's high ethical standards and code of conduct.
• Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs.
• Provides direction in discussing and creating development plans.
• Aligns individual goals for self and others with work area/functional goals.
• Works within budgetary/ financial objectives set by manager, applying knowledge of profit drivers to work processes within own area.
• Builds confidence and respect of others through a positive and energizing style.
• Is aware of internal/external business issues and adapts work priorities in own area.
• Works with customers to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others.
• Encourages subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work.
• Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view.
• Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team members, regardless of background; mentors and empowers others to achieve success
• Effectively listens to and explains difficult issues to reach shared understanding and build alignment
• Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the Indy manufacturing site philosophy and vision. Is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

• Coordinates and supervises the daily activities of Chemists or business support staff in the performance of technology transfer, method validation/verification and method optimization
• Serves as the liaison between Cardinal Health Quality Control and Client Quality Control in the performance of technology transfer, method validation/verification/development/optimization
• Is a quality lead for the QC Chemistry team
  • Identifies quality events and works with QA/QC management to ensure each event is handled in accordance with site procedures and regulatory requirements
• Oversees chemists and contractors who operate analytical equipment, perform analytical tests, interpret results and documents findings in accordance with SOPs and regulatory requirements.
• Trains, assesses and coaches team in laboratory procedures, techniques and career development as needed.
• Performs technical review of investigations, deviations and CAPAs.
• Oversees and authors written procedures and other documents, including amendments.
• Ensures results are consistent with acceptable test parameters and reports abnormal findings from Analytical tests to the Manager of Quality Control (Chemistry).
• Ensures employees operate within guidelines, all necessary testing is carried out, and the associated records provided to the QA department in a timely manner to ensure project timelines are met
• Assists in the recommendation for approval or rejection of testing methods and modes of analysis
• Develops and applies practices which will enable the laboratory to meet and exceed desired customer and regulatory standards in a cost-effective fashion.
• Assists in and/or conduct all laboratory investigations of discrepancies to resolve problems and works with other members of management to ensure corrective action or preventative actions are implemented in a timely manner.
• Remains aware of developments in chemistry by reading current technical literature and attending technical meetings.
• Makes recommendations to other members of management to improve the performance of the laboratories.
• Ensures proper laboratory hygiene and monitors the storage conditions for materials and products used in the labs.
• Executes or participates in internal/external laboratory quality audits, as directed by management to ensure that all associated records are evaluated.
• Assists in training efforts and development of laboratory personnel.
• Works closely with operations regarding the interpretation and implementation of any elements that the system of the Quality Management System, to resolve differences and ultimately ensure the system is understood and applied uniformly.
• Ensures all work is carried out in a manner demonstrating support for and adherence to the Company’s Safety Policy and Procedures, Quality Policy and Procedures, Ethics Policy, Environmental management System, Vision and Strategy, and to exercise good judgement, common sense, and diplomacy in doing so.
• Produces and reviews personal development plans for team members, identifying and providing appropriate training.
• Ensures any Safey, Quality, or Site actions are completed effectively and in a timely manner and that the escalation process exists to raise quality issued to the appropriate levels of management.
• Performs other job duties as assigned.