Supervisor, Quality Control Chemistry

Supervisor, Quality Control (Chemistry) – Second Shift

Cardinal Health – develop innovative products and services that make healthcare safer and more productive.

• Second Shift – Anticipated Monday‑Friday 3:00 pm – 12:00 am
• Potential to work 1st shift to cover PTO of other analysts
• Initial training for this role will be provided on 1st shift

• Supervises the daily activities of Chemists or business support staff in the analysis of raw materials, drug substance, in‑process and drug product testing
• Is a quality lead for the QC Chemistry team while limited management presence is available on 2nd shift
• Identifies quality events and works with QA/QC management remotely to ensure each event is handled in accordance with site SOPs 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
• Leads and facilitates the qualification of analytical instrumentation, verification of compendia analytical methods, stability studies
• Performs technical review of investigations, deviations and CAPAs
• Oversees and authors written procedures and other documents, including amendments
• Leads team members through the analytical method transfer process
• 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 are evaluated
• Assists in the recommendation for approval or rejection of starting materials, intermediate, and finished products
• 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
• Plays a key role in the creation of analytical equipment qualification protocols and timely delivery of analytical equipment in the various quality control rooms. Oversees the execution of all qualification protocols and ensure proper IOQ task completion
• Ensures any Safety, Quality, or Site actions are completed effectively and in a timely manner and that the escalation process exists to raise quality issues to the appropriate levels of management
• Performs other job duties as assigned

• Bachelor’s degree in chemistry or related science field; experience in radiochemistry, nuclear pharmacy, or health physics preferred
• 6+ years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry preferred (Pharmaceutical or Medical Device)
• Must have experience with…