What QRA Management contributes to Cardinal Health
QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.
* Oversees the Microbiology laboratory systems to ensure that the data generated by the laboratories are produced in accordance with all applicable regulations and company policies and procedures.
* Oversees and maintains the Environmental Monitoring Program as required.
* Recommends approval or rejection of starting materials, intermediate, and finished products.
* Develops and applies practices, which will enable the laboratory to meet and exceed, desired customer and regulatory standards in a cost effective fashion.
* Collaborates with validation team and maintenance regarding lab equipment in the microbiology labs to determine conformance with applicable procedures and good practices.
* Responsible for the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
* Ensures that all necessary testing is carried out and the associated records are evaluated.
* Assists in and/or conduct all laboratory investigations of discrepancies to resolve problems and works with Management to ensure corrective action or preventive actions are implemented in a timely manner.
* Remains aware of developments in microbiology by reading current technical literature and attending technical meetings.
* Makes recommendations to management to improve the performance of the laboratories.
* Ensures proper laboratory hygiene and monitors the storage conditions for materials and products used in the labs.
* Fosters an environment that ensures both timely and effective communication as well as the escalation process to raise quality issues to the appropriate levels of management.
* Advises in the purchase of those laboratory supplies which have a direct effect on quality.
* Assists in the training efforts and development of the laboratory personnel.
* Carries out the above responsibilities, in a manner demonstrating support for and adherence to the Company's Safety Policy and Procedures, Quality Policy and Procedures, Ethics Policy, Environmental Management System, Vision and Strategy, and to exercise good judgment, common sense, and diplomacy in so doing.
* Produces and reviews personal development plans for team members, identifying and providing appropriate training.
* Ensures any Safety, Quality or Site actions are completed effectively and in a timely manner and that the escalation process exists to raise quality issues to the appropriate levels of management.
* Performs other job duties as assigned.
* Bachelor's degree in related field (Microbiology or Biology) or equivalent work experience preferred
* 8+ years experience in related field, preferred and working in an FDA regulated industry (Pharmaceutical or Medical Device)
* Must have experience with equipment qualification, test method validation, environmental monitoring, and/or process validation.
* Must have experience with writing procedures/ reports and execution of laboratory tests.
* Must work well with others and understand how to be successful in a Team environment.
* Must be detail oriented, organized, able to multi-task, a self starter, and self motivated.
* Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
* A Covid-19 vaccination is required in order to be employed in this position. This includes either:
* 2 doses of the Moderna or Pfizer vaccine
* 1 dose of the Johnson & Johnson vaccine
What is expected of you and others at this level
* Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
* Participates in the development of policies and procedures to achieve specific goals
* Ensures employees operate within guidelines
* Decisions have a short term impact on work processes, outcomes, and customers
* Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
* Interactions normally involves resolution of issues related to operations and/or projects
* Gains consensus from various parties involved
Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines
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.