Principal Quality Assurance Specialist - Cardinal Health
Harrisburg, PA
About the Job
_What Quality Systems Management contributes to Cardinal Health_
Quality Assurance is responsible for the development, deployment, and maintenance of a compliant and cost-effective quality systems. Quality Assurance is responsible for assessing processes and practices for regulatory risk and conformance to quality standards and working with business and quality leaders to implement improvements.
_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
+ 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
_Responsibilities_
+ Responsible for maintenance the integrity of the Learning and Quality Management systems, including the oversite and development of training curriculums and programs.
+ Perform day to day activities relating to support requests from business units in both the Learning Management System (LMS) and Quality Management System (QMS).
+ Creates, organizes & updates training content and curricula, such as controlled documents and courses.
+ Assists end users in basic questions relating to the LMS or QMS workflow modules (CAPA, Audit, Document Management).
+ Demonstrates comprehensive knowledge of relevant regulatory regulations, standards and standard operating procedures (SOPs) in the respective areas.
+ Partner with the IT department to maintain applicable LMS/QMS process and tools and to participate in improvement efforts.
+ Creates/updates user accounts and permissions based on access requests.
+ Perform system administration duties such as user & user group management, troubleshooting basic system issues and providing basic technical support.
+ Maintains visibility on the status of incident tickets and re-assigns/escalates as needed.
+ Works well cross-functionally. Can collaborate influence others on requirements.
+ Assists with System Validation Testing activities related to enhancement releases to include script creation and testing.
+ Participate and manage various projects/tasks as assigned.
_Qualifications_
+ Bachelors in related field, preferred or equivalent work experience
+ 4+ years’ experience in related field, preferred
+ Experience with Learning Management Systems (ComplianceWire) and Quality Management Systems (Veeva)
+ Current knowledge on GMP & regulation (FDA CFR 820 & CFR 210/211, & ISO13485) & international quality system requirements
+ Ability to write reports, business correspondence and procedure manuals.
+ Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
+ Knowledge e-learning authoring software a plus.
Travel Required: Low (1-2 times a year)
This position is 100% remote.
Anticipated salary range : $79,700 - $113,800
Bonus eligible : No
Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
Application window anticipated to close: 1/3/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
#LI-MP1
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Quality Assurance is responsible for the development, deployment, and maintenance of a compliant and cost-effective quality systems. Quality Assurance is responsible for assessing processes and practices for regulatory risk and conformance to quality standards and working with business and quality leaders to implement improvements.
_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
+ 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
_Responsibilities_
+ Responsible for maintenance the integrity of the Learning and Quality Management systems, including the oversite and development of training curriculums and programs.
+ Perform day to day activities relating to support requests from business units in both the Learning Management System (LMS) and Quality Management System (QMS).
+ Creates, organizes & updates training content and curricula, such as controlled documents and courses.
+ Assists end users in basic questions relating to the LMS or QMS workflow modules (CAPA, Audit, Document Management).
+ Demonstrates comprehensive knowledge of relevant regulatory regulations, standards and standard operating procedures (SOPs) in the respective areas.
+ Partner with the IT department to maintain applicable LMS/QMS process and tools and to participate in improvement efforts.
+ Creates/updates user accounts and permissions based on access requests.
+ Perform system administration duties such as user & user group management, troubleshooting basic system issues and providing basic technical support.
+ Maintains visibility on the status of incident tickets and re-assigns/escalates as needed.
+ Works well cross-functionally. Can collaborate influence others on requirements.
+ Assists with System Validation Testing activities related to enhancement releases to include script creation and testing.
+ Participate and manage various projects/tasks as assigned.
_Qualifications_
+ Bachelors in related field, preferred or equivalent work experience
+ 4+ years’ experience in related field, preferred
+ Experience with Learning Management Systems (ComplianceWire) and Quality Management Systems (Veeva)
+ Current knowledge on GMP & regulation (FDA CFR 820 & CFR 210/211, & ISO13485) & international quality system requirements
+ Ability to write reports, business correspondence and procedure manuals.
+ Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
+ Knowledge e-learning authoring software a plus.
Travel Required: Low (1-2 times a year)
This position is 100% remote.
Anticipated salary range : $79,700 - $113,800
Bonus eligible : No
Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
Application window anticipated to close: 1/3/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
#LI-MP1
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Source : Cardinal Health