The primary function of the Quality Assurance and Regulatory Compliance Principal Specialist is to support the pharmaceutical drug stability program. This position will be responsible for the coordination of third-party laboratories, directing stability samples to individual labs, compiling laboratory results, supporting validation efforts, new product introduction, procedure drafting and revisions as it pertains to the stability program.
What Quality Assurance contributes to Cardinal Health
Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Ensuring compliance with regulations as well as internal procedures.
Perform data entry of test results into stability tracking software.
Communicate with the manufacturers and 3rd party laboratories as it pertains to the testing of product.
Perform monthly and annual trending of stability test results.
Ensure Quality Agreements are signed with each manufacturer/vendor and ensure compliance to the agreement.
Assist manufacturer/vendor with investigating OOS results.
Interact with internal stakeholders to assist in ensuring compliance with internal procedures.
Proactively identify, investigate and make recommendations within the position’s scope of responsibilities, effectively communicating on a timely basis to the Manager, Quality Assurance and Regulatory Compliance.
Develop, review and implement QA department procedures as well as assist with reviewing procedures for other groups.
As they relate to regulatory compliance and the position’s scope of responsibility.
Assist in the execution of in-house validation programs as it pertains to the stability software validation.
Participate in and contribute to team meetings such as project team meetings, validation team meetings, etc.
Assist/support all corporate or agency inspections, as required.
Bachelors in related field (pharmaceutical sciences), or equivalent work experience, preferred
4+ years experience in related field, preferred
What is expected of you and others at this level
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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