Supervisor, Quality Control Chemistry (Weekend Shift)

Cardinal Health•Indianapolis, IN

13d•Onsite

About The Position

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. What a Supervisor, Quality Control (Chemistry) contributes to Cardinal Health Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. Demonstrates detail-oriented attention in all facets of responsibilities. Performs analytical evaluation and/or testing of products or processes. Has knowledge of testing methods, product usage, and applicable regulations and standards. Established test methodology and adheres to established policies and procedures. Provides technical guidance and training to others on SOPs and quality guidelines.

Requirements

Bachelor’s degree in chemistry or related science field.
6+ years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry preferred (Pharmaceutical or Medical Device).
Must understand the validation and technology transfer process and have experience with writing procedures/reports and execution of laboratory tests preferred.
Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills preferred.

Nice To Haves

Experience in radiochemistry, nuclear pharmacy, or health physics preferred.
Must have experience with equipment qualification, software validation, test method validation, and/or process validation preferred.
Has experience in authoring a variety of documentation such as SOPs, Change Controls, CAPAs, Deviations (Nonconformance), and Laboratory Investigations preferred.

Responsibilities

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 weekend 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 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.