QC Microbiology Manager

Cardinal Health; Legendary Hills (IN); On-site; USD 107,000 - 152,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day (myFlex

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Job summary

Cardinal Health is seeking a Quality Assurance leader to oversee microbiology laboratory systems and environmental monitoring, ensuring compliance with 21 CFR rules and company policies. The role emphasizes implementing quality policies, driving improvements, and collaborating across functions to deliver reliable, safe, and effective products.

You will manage budgets and guide personnel while advancing laboratory testing, validation, and risk assessment.

Qualifications

• BS in Microbiology, Biology, or related science field; advanced degree preferred.
• Experience with 21 CFR 210/211 in FDA-regulated industry (Pharmaceutical or Medical Device).
• Experience with equipment qualification, software validation, test method validation, environmental monitoring, and/or process validation.
• Strong technical writing skills and ability to write procedures/reports.

Responsibilities

• Oversees microbiology laboratory systems and data per regulations.
• Manages Environmental Monitoring Program and lab testing.
• Conducts laboratory investigations and leads CAPA efforts.
• Trains and develops laboratory personnel; manages resources and budget.

Skills

Teamwork

Attention to detail

Technical writing

MS Word

MS Excel

Education

BS in Microbiology

Advanced degree preferred

Tools

Equipment qualification

Software validation

Test method validation

Environmental monitoring

Process validation

Job description

What Quality Assurance contributes to Cardinal HealthQuality 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.What is expected of you and others at this levelRole models Cardinal Health's high ethical standards and code of conduct.Manages department operations and supervises professional employees, frontline supervisors, contractors, and/or business support staff. Applies expertise to improve effectiveness and provide guidance to employees in own area.Cascades organizational goals to the individual level ensuring that individuals understand how they can contribute by establishing goals and achieving results within own job family, holding self and others accountable for results.Builds confidence and respect of others through a positive and energizing style.Proactively identifies talent internally and externally, including participation in succession planning process for job family.Encourages direct reports to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work.Has accountability for managing financial resources. Manages budget for own area and allocates resources accordingly, applying knowledge of profit drivers within own area/job family.Develops processes and procedures to implement functional strategies.Makes decisions, often difficult and/or unpopular, that impact the work of direct reports within job family; influences direct reports to support decision by presenting rationale/business case.Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs.Interprets internal/external business issues and adapts work priorities in own area.Works with customer groups to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others.Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view.Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the IMS philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.AccountabilitiesOversees 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.QualificationsB.S. degree in Microbiology, Biology, or related science field. Advanced degree preferred.At least 710 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).Must have experience with equipment qualification, software validation, test method validation, environmental monitoring, 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.Must be detail oriented, organized, able to multitask, a self-starter, and self-motivated.Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.Anticipated salary range: $106,700.00-$152,400.00Bonus eligible: NoBenefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 12/29/2026 *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.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 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