Sr. Specialist, Quality Assurance - Cardinal Health
Indianapolis, IN
About the Job
_What Quality Assurance 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 Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.
_Responsibilities_
+ Demonstrates knowledge of learning/quality management systems and approaches.
+ Demonstrates comprehensive knowledge of relevant regulatory regulations, standards and standard operating procedures (SOPs) in the respective areas.
+ Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager.
+ Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
+ Applies judgment within defined parameters.
+ Receives general guidance and may receive more detailed instruction on new projects
+ Work reviewed for sound reasoning and accuracy.
+ 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.
+ Supports the release of new/updated documents into the LMS ensuring proper processes are followed.
+ Assists end users in basic questions relating to the LMS or QMS workflow modules (CAPA, Audit, Document Management).
+ 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.
+ Performs System Validation Testing as needed.
+ Other related tasks and projects as assigned.
_Qualifications_
+ 2-4 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
+ Medical Device, Pharmaceutical or Healthcare experience preferred
+ solid working knowledge of FDA, ISO and international medical device regulations is highly desired.
+ Experience with the following:
+ Quality Management Systems (Veeva)
+ Learning Management System software UL ComplianceWire
+ web-based authoring software (Storyline 360)
Anticipated salary range : $67,500 - $96,400
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: 1/31/2025 *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 develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.
_Responsibilities_
+ Demonstrates knowledge of learning/quality management systems and approaches.
+ Demonstrates comprehensive knowledge of relevant regulatory regulations, standards and standard operating procedures (SOPs) in the respective areas.
+ Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager.
+ Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
+ Applies judgment within defined parameters.
+ Receives general guidance and may receive more detailed instruction on new projects
+ Work reviewed for sound reasoning and accuracy.
+ 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.
+ Supports the release of new/updated documents into the LMS ensuring proper processes are followed.
+ Assists end users in basic questions relating to the LMS or QMS workflow modules (CAPA, Audit, Document Management).
+ 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.
+ Performs System Validation Testing as needed.
+ Other related tasks and projects as assigned.
_Qualifications_
+ 2-4 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
+ Medical Device, Pharmaceutical or Healthcare experience preferred
+ solid working knowledge of FDA, ISO and international medical device regulations is highly desired.
+ Experience with the following:
+ Quality Management Systems (Veeva)
+ Learning Management System software UL ComplianceWire
+ web-based authoring software (Storyline 360)
Anticipated salary range : $67,500 - $96,400
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: 1/31/2025 *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