Description:
* Perform predetermined sampling and testing to ensure that all the controlled environment rooms and water systems meet the environmental specifications requirements.* Perform the raw materials and finished product required sampling and testing.* Collect the pre-determined samples and deliver to external laboratories for testing.* Coordinates the sampling of product sent to external laboratories for testing.* Maintain the necessary testing supplies in stock.* Manage media inventory and generate purchasing requisitions as required.* Review and approves, as required, routine test results.* Releases sterilized product.* Executes investigations on out of specification test results for environmental and sterilization processes.* Provides technical review and disposition, as required, or raw materials, in-process and finished goods regarding microbiology related issues.* Executes projects, generate protocols and investigations for the improvement and support of the manufacturing areas and for new product transfer.* Coordinates dose audit and dose mapping with external contractors.VALIDATION AND CALIBRATION.* Validates the manufacturing sterilizers, the CAE rooms and supporting systems, water systems and completes any related documentation.* Maintains all required laboratory instruments and equipment validated and/or calibrated and coordinates with calibration personnel any required activities.* Executes micro related validations for the new product transfer and for changes to the manufacturing process.* Validate required laboratory equipment and complete the required documentation.DOCUMENTATION.* Maintain and file all laboratory test data and reports according to requirements and coordinate their delivery to documentation area for final record retention.* Evaluates and maintains trend charts of environmental test data, water system, product tests and other microbiology related data.* Maintains traceability of clinical product used for testing.* Conducts investigations and generates reports for out of specifications.* Monitors laboratory key indicators and metrics.* Analyze environmental data results and lab testing results. Generate charts for quality meetings.* Handling and maintain the extraordinary changes process for the controlled areas.* Handling and maintain the environmental corrective action process.* Prepare quality reports as required.TRAINING (If certified)* Provides training to new Microbiologist on test methods and procedures.* Provide training to all new employees in environmental, hygiene, product sampling as part of the on-boarding process.Ensure compliance with all applicable procedures and regulatory agency requirements.Other duties as assigned.
Skills:
Microbiology, Environmental monitoring, Raw material testing
Top Skills Details:
The primary function of this position is to perform all tests or processes required to monitor the production area environment. The individual will be responsible for carrying out assigned tasks which could include laboratory experiments and testing of raw material and processes.
Additional Skills & Qualifications:
Education Level Major/Field of StudyBachelor’s Degree Microbiology or Natural SciencesExperience:Minimum of one to three years’ experience in medical devices laboratory is required.Must have knowledge of Good Laboratory Practices (GLP's) and use of basic lab equipment such as pH meter, analytical balance, incubator, autoclave, etc.Knowledge in industrial sterilization such as steam, EO and gamma radiation methods, and water systems preferable.Fully bilingual (English and Spanish).Must have demonstrated ability to work in a team environment.Knowledge in computer applications programs as Excel, Words, Power Point, etc."
Experience Level:
Intermediate LevelAbout Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
