Sterility Assurance Scientist

What Sterility Assurance contributes to Cardinal Health

This position reports into Sterility Assurance and is responsible for the support and management of site level Sterility Assurance programs such as Environmental Monitoring, Bioburden Monitoring and/or Gamma Dose Audit program monitoring.

As well as perform different functions in laboratory tests to verify compliance with the specifications, decision-making on issues related to product quality and controlled environments. In addition, they must ensure regulatory compliance in the documentation.

Accountabilities

• Conduct and interpret Environmental monitoring testing
• Conduct laboratory investigations
• Manage inventory control for laboratory supplies
• Participate in the coordination of the laboratory activities/tests/environmental monitoring
• Provide support in the validation of laboratory equipment.
• Execute cleaning tasks, as well as any operation associated with the good maintenance of laboratory equipment
• Responsible for notifying damage or repair needs in the instruments, processing the maintenance service with the appropriate personnel.
• Collection and submission of samples per the established sampling schedule for bioburden and /or Dose audit process as required, or any other sample required
• Ensuring that the Dose Audit and bioburden schedule is maintained.
• Interpret and trend bioburden testing
• Responsible for Data trending and maintenance of the EM and bioburden testing.
• Authoring and maintenance of procedure, policy, and form updates within quality system

Qualifications

• High school Diploma
• Bachelor’s degree completed in microbiology, biotechnology, chemistry, biology or related field preferred or equivalent industry experience.
• Minimum 1 years working in Microbiology area (preferred)
• Medical devices industry experience (Preferred)
• Knowledge related to the microbiology area.
• Knowledge in Aseptic Technique.
• Knowledge in Microsoft Office package
• General knowledge of industry regulations pertaining to GMPs, GDPs and GLPs
• LIMS knowledge
• English level: intermedium
• Knowledge in data management

What is expected of you and others at this level

• Attention to detail.
• Ability to work with cross-functional teams
• Adheres to established policies and procedures
• Ability to work proactively and independently.
• Ability to multi-task and efficient in time management.
• Excellent verbal communication and interpersonal skills

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.