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Company Name : Ultimate Staffing Services
Location : Phoenix, AZ 85044
Position : Microbiologist (JO-2203-151689)
Job Description : Our medical device technologies firm in Phoenix, AZ is looking for a Microbiologist
Location: onsite, Phoenix, AZ
Duration: 6 months with possible extension
Pay Terms: up to $83.00 hr. on W-2
Job Summary:
Identify, isolate and study microorganisms and their byproducts as it relates to the sterilization of medical devices. Maximize the biocompatibility of products using industry guidelines and advanced testing technologies. Work closely with operations groups to lead continuous quality improvement initiatives. Coordinate and complete projects with minimal supervision.
Essential Duties and Responsibilities:
Reporting to the Sterility Assurance Manager, this position’s incumbent is the subject matter expert for sterilization process including the following elements.
Sterilization related testing for qualification and requalification Sterilization Process Controls, Monitoring Program and related testing Sterilization Processes (VH2O2, EO and Gamma)
Sterilization Cycle Development and Validations (if needed)
Non conformance Investigations and CAPA in the following areas
Sterilization Controls
Product Batch Record Review
Product Final Disposition.
Adhere to the company’s policies and procedures.
Continuously fully complies with all regulatory and quality system requirements.
Assure and enforce compliance to sterilization controls regulatory requirements as they relate to the production and release of sterile products.
Provide critical analysis, decision making, and the origination of Position Statements for local and companywide deployment as needed
Sterilization Controls
Ensure that the appropriate documentation and procedures are established and reviewed as per latest regulatory requirements to assure compliance to the sterilization control sub-system.
Effectively follow up to interactions of all control and monitoring processes/programs within the Sterilization Controls sub-system elements as defined above to assure product sterility.
Effectively follow up to interactions of all control and monitoring processes/programs within the ECA to assure compliance to regulatory requirements.
Effectively follow up on all documentation related to final product release.
Ensure the appropriate educational tools and programs are in place to assure product sterility and disposition.
Monitor the state of the Sterilization Controls sub-system, the Environmental Controlled Areas, Batch Record Review and Product Disposition through tracking and trending, monthly reports and product/system audits as applicable and identifying areas of opportunity and possibilities for growth.
Ensures regulatory compliance by evaluating proposed changes as they relate to the Sterilization Controls requirements.
Conducts & documents sterilization controls, environmental controlled areas and Product disposition related investigations as needed. Conducts Risk Assessments.
Conducts & Reviews NC reports and CAPA Projects Establishes (defines, documents, and implements) procedures for sterility assurance elements, environmental controlled areas and product disposition as needed.
Establishes policies and practices related to behavior, control, and access to all environments.
Prepare protocol and reports for different sterilization validations methods following .
Execute, gather and prepare sterilization validation activities.
Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and
biocompatibility analysis of medical devices.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Lead in the development, review a
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