Manager, QC Chemistry

Cardinal Health•Indianapolis, IN

10h

About The Position

What Manager, Quality Control contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Management provides strategic oversight, leadership and direction within the Quality function. Responsibilities Quality control is responsible for the analysis or inspection of products or processes for compliance with specifications and standards. Demonstrates detailed oriented attention in all facets of responsibilities. Performs analytical evaluation or test of products or processes. Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards. Adheres to established policies and procedures. Establishes test methodology. Provides technical guidance and training to others on SOPs and quality guidelines. Responsible for ensuring Method Transfers adhere to required timelines. Qualifications A Bachelor’s degree in related field, or equivalent work experience, preferred Bachelor’s degree in related field, or equivalent work experience, preferredt least 7-10 years of relevant work experience working in an cGMP regulated industry. Thorough understanding of 21 CFR 210, 211, European requirements, USP, and EP testing requirements. Must have experience with equipment qualification, software validation, test method validation, and/or process validation. Must understand the Validation and Technology Transfer process and have experience with writing procedures/ reports and execution of laboratory test. Must work well with others and understand how to be successful in a Team environment, including building and developing a high functioning team. Must be detail oriented, organized, able to multitask, a selfstarter, and selfmotivated. What is expected of you and others at this level Manages department operations and supervises professional employees and Supervisors Participates in the development of policies and procedures to achieve specific goals Ensures employees operate within guidelines Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management Interactions normally involve resolution of issues related to operations and/or projects Gains consensus from various parties involved

Requirements

A Bachelor’s degree in related field, or equivalent work experience, preferred
At least 7-10 years of relevant work experience working in an cGMP regulated industry
Thorough understanding of 21 CFR 210, 211, European requirements, USP, and EP testing requirements
Must have experience with equipment qualification, software validation, test method validation, and/or process validation
Must understand the Validation and Technology Transfer process and have experience with writing procedures/ reports and execution of laboratory test
Must work well with others and understand how to be successful in a Team environment, including building and developing a high functioning team
Must be detail oriented, organized, able to multitask, a selfstarter, and selfmotivated

Responsibilities

Analysis or inspection of products or processes for compliance with specifications and standards
Performs analytical evaluation or test of products or processes
Adheres to established policies and procedures
Establishes test methodology
Provides technical guidance and training to others on SOPs and quality guidelines
Responsible for ensuring Method Transfers adhere to required timelines
Manages department operations and supervises professional employees and Supervisors
Participates in the development of policies and procedures to achieve specific goals
Ensures employees operate within guidelines
Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
Gains consensus from various parties involved