Supervisor, Quality Control Chemistry

Supervisor, Quality Control (Chemistry)

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Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards.

Responsibilities include :

• Supervising the daily activities of Chemists or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing.
• Acting as a quality lead for the QC Chemistry team while limited management presence is available on 2nd shift.
• Overseeing chemists and contractors who operate analytical equipment, perform analytical tests, interpret results and documents findings in accordance with SOPs and regulatory requirements.
• Training, assessing and coaching team in laboratory procedures, techniques and career development as needed.
• Leading and facilitating the qualification of analytical instrumentation, verification of compendia analytical methods, stability studies.
• Performing technical review of investigations, deviations and CAPAs.
• Overseeing and authoring written procedures and other documents, including amendments.
• Leading team members through the analytical method transfer process.
• Ensuring results are consistent with acceptable test parameters and reporting abnormal findings from Analytical tests to the Manager of Quality Control (Chemistry).
• Ensuring employees operate within guidelines, all necessary testing is carried out, and the associated records are evaluated.
• Assisting in the recommendation for approval or rejection of starting materials, intermediate, and finished products.
• Developing and applying practices which will enable the laboratory to meet and exceed desired customer and regulatory standards in a cost-effective fashion.
• Assisting in and / or conducting all laboratory investigations of discrepancies to resolve problems and working with other members of management to ensure corrective action or preventative actions are implemented in a timely manner.
• Remaining aware of developments in chemistry by reading current technical literature and attending technical meetings.
• Making recommendations to other members of management to improve the performance of the laboratories.
• Ensuring proper laboratory hygiene and monitoring the storage conditions for materials and products used in the labs.
• Executing or participating in internal / external laboratory quality audits, as directed by management to ensure that all associated records are evaluated.
• Assisting in training efforts and development of laboratory personnel.
• Working 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.
• Ensuring 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.
• Producing and reviewing personal development plans for team members, identifying and providing appropriate training.
• Playing a key role in the creation of analytical equipment qualification protocols and timely delivery of analytical equipment in the various quality control rooms. Overseeing the execution of all qualification protocols and ensure proper IOQ task completion.
• Ensuring 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.
• Performing other job duties as assigned.

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Qualifications include :

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What is expected of you and others at this level :

Anticipated salary range : $76,700 - $113,800