Scientist, Sterility Assurance

hace 1 semana

México Cardinal Health A tiempo completo

**_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 Quarterly Dose Audit (QDA) program monitoring. Responsible for coordination and oversight of off-site testing related to the site Environmental Monitoring, Bioburden and/or Dose Audit Programs.

**_ Accountabilities_**
- Conduct and interpret Environmental Monitoring testing
- Conduct laboratory investigations
- Manage inventory control for laboratory supplies
- Participate in the coordination of the laboratory activities
- Provide support in the validation, maintenance and cleaning of laboratory equipment and laboratory
- Collection and submission of samples per the established sampling schedule for bioburden and /or Dose audit process as required, or any other sample required
- Responsible for Data trending and maintenance of the site EM and bioburden/QDA programs, including the sample pull schedule for the site.
- Execute Alert and Action Limit calculations according to CAH procedures and applicable ISO standards for all programs
- Authoring and maintenance of procedure, policy, and form updates within quality system
- Generate trending metrics for EM and bioburden/QDA programs
- Work cross-functionally with internal microbiology labs and other site departments to support Change Development Processes (CDPs)

**_ Qualifications_**
- 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 (preferred)
- English level: intermediate
- 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
- 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._

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