Lab Analyst
$17.1 - $28.3 per hourCardinal Health
What Sterility 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. Sterility Assurance performs technical studies and specialized laboratory testing to ensure that the risk of microbial contamination in our medical device product is controlled and appropriately low in our sterile product. This job family develops and executes precise monitoring and testing procedures to report on quality and regulatory science-based results in accordance with internal and external requirements.
This position is 100% onsite in Deland, FL and is first shift (Monday to Friday). Responsibilities
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Sterility Assurance performs technical studies and specialized laboratory testing to ensure that the risk of microbial contamination in our medical device product is controlled and appropriately low in our sterile product. This job family develops and executes precise monitoring and testing procedures to report on quality and regulatory science-based results in accordance with internal and external requirements.
This position is 100% onsite in Deland, FL and is first shift (Monday to Friday). Responsibilities
- Perform microbiological assays such as: Sterility Tests of Products and Biological Indicators, Bioburden, Bacteriostasis and Fungi stasis, Media Preparation, Growth Promotion, Environmental and Water Analysis, Microbial Limits of Raw Materials and Finished products, Antimicrobial Effectiveness, Bioassays, LAL, Cytotoxicity, & Gram Stain
- Preparation of media and reagents
- Maintain accurate records data of test records throughout LIMS.
- Provides cross training and guidance on advanced technologies, instrumentation, and procedures to laboratory personnel to ensure continuous quality data.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- Provide general assistance in the laboratory, ordering supplies, and maintaining an orderly workspace as needed.
- Operate and properly maintain Laboratory Equipment and Instrumentation. Ensure that equipment maintenance is properly documented in a timely manner.
- Bachelor's degree in Microbiology or related discipline, or equivalent work experience, preferred
- 1-2 years of lab experience preferred
- Understanding of microbiological principles
- Technical report writing ability and strong communication skills preferred
- Familiar with FDA, ISO and GMP regulations
- Applies acquired knowledge and skills to complete standard tasks
- Readily learns and applies new information and methods to work in assigned area
- Maintains appropriate licenses, training and certifications
- Works on routine assignments that require some problem resolution
- Works within clearly defined standard operating procedures and/or scientific methods
- Adheres to all quality guidelines
- Works under moderate degree of supervision
- Work typically involves regular review of output by work lead or supervisor
- Refers complex unusual problems to supervisor
- 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
Vacancy posted 16 hours ago
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