Senior Specialist, Quality Control (Incoming Materials)

Cardinal Health•Indianapolis, IN

23h•Hybrid

About The Position

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. Reports to Supervisor, Quality Control (Incoming Materials). Performs visual inspection, dimensional measurement, physical characterization and analytical evaluation or test of products and processes. Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards. Adheres to established policies and procedures. Establishes test methodology and may contribute to the development of policies and procedures. May provide technical guidance and training to others on SOPs and quality guidelines.

Requirements

Bachelor’s degree or previous work experience in a similar role or related field, such as materials management or warehouse.
2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
Serves as a technical lead of Quality Control regarding incoming GMP material inspection and physical characterization testing.
Collaborates with multiple Cardinal Health departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site and coordinates payment with procurement.
Has knowledge and is able to execute work within the SAP system.
Exhibits Cardinal Health's high ethical standards and code of conduct.
Aligns work priorities with immediate supervisor.
Approaches work situations with a positive and energizing style.
Gains awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between QC and your role.
Exhibits professional conduct, respect for others, and understands how to be successful in a team environment.
Actively participates in improving work processes to meet and exceed expectations, identifying opportunities for improvement.
Reports errors in a timely and appropriate manner.
Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
Is detail oriented, organized, has the ability to multi-task, and is self-motivated.
Is aware of internal/external business issues and adapts work priorities in own area.
Demonstrates strong communication skills.
Effectively listens to and explains difficult issues to reach shared understanding and build alignment.
Has the ability to act calmly and patiently when working under pressure and/conditions of stress.
Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

Responsibilities

Ensures timely and thorough inspections and analysis of incoming, raw, and GMP printed materials.
Creates MIC codes and inspection plans in SAP system and material specifications within the document management system.
Keeps track of purchase orders related to incoming materials.
Follows standard operating procedures, analytical methods, and specifications and completes required documentation.
Performs investigations, deviations, change controls, and CAPAs as applicable.
Authors and optimizes SOPs, analytical testing forms, and other documents as necessary.
Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
Supports the Principal Specialist, Quality Control – Incoming Materials, to serve as the backup liaison between Quality Control and external service vendors and may assist in the scheduling of testing and timely receipt of reported results from eternal service vendors for the purpose of releasing incoming GMP material.
Is a lead collaborator on behalf of Quality Control with different departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site.
Authors laboratory investigations, change controls, deviations, and corrective/preventative actions as needed.
Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
Performs other job duties as assigned.