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location: Bedford, Massachusetts
job type: Contract
salary: $25.42 - 29.90 per hour
work hours: 9 to 5
Under the supervision of the QA Manager, assure product claims are met, by management and supporting performance of microbiological tests associated with new or existing products or processes, contamination control and product release.
As a member of the Quality group, responsible for the development and implementation of individual and organizational strategies maintaining a high-performance work team culture and focusing on the plant goals of safety, quality, schedule, cost and team development.
Development and validation of new and improved microbiological methods. Review environmental condition of classified areas, maintain database for environmental monitoring, water monitoring, bacti/fungi and endotoxin test results and summarize data for annual metrics report. Ability to conduct various studies that support the validity of the QA microbiology department including cleaning validations, disinfectant efficacy studies, growth promotion and media qualification.
- Deliver sterile products to market on schedule without biological quality defect through the review of laboratory results and sterilization records for final lot release approval.
- Provide technical guidance and educational training to manufacturing in the area of microbiological testing and environmental practices.
- Manage, Execute and maintain the Sterility Maintenance Program.
- Manage, Execute and maintain the environmental monitoring program including the co-ordination of cleanroom certification and associated personnel. Duties may include test performance.
- Measurement system analysis and validation of laboratory equipment.
- Develop and validate protocols for laboratory testing of products and materials.
- Develop and maintain work instructions for laboratory testing of products and materials.
- Provide training for laboratory and production personnel as necessary.
- Work closely with the QA Manager to review technical problems, suggest solutions and anticipate major problems to key operations.
- Coordinate analysis of microbial and environmental product/process problems using communications with production personnel and laboratory.
- Perform and report trend analyses of laboratory test results, lot failures.
- Performs investigations and root cause analysis activities in support of resolution of sterility failures, contamination events, etc.
- Maintain accurate and current records of all results and procedures. Must be able to assure a high degree of accuracy in all tests results obtained.
- Coordinate the collection and set-up laboratory test samples according to documented procedures.
- Manage and monitor the performance of routine preventative maintenance and monitoring of laboratory equipment and supplies.
- Bachelor's degree in Microbiology
- Minimum of two years of experience in industrial microbiology with microbiology testing experience
- Proficiency with qualitative and quantitative microbiological tests.
- Proficiency within the laboratory, to include sterile technique, instrumental analysis,
- Laboratory testing/Identification, recording/analyzing data.
- Knowledge of Environmental monitoring, Bioburden test, Bacti/Fungi test, Endotoxin test.
- Problem solving techniques to perform investigations and drive root cause analysis.
- Demonstrated experience with ISO, GMP or GLP.
- Ability to multi-task.
- Strong interpersonal and communication skills.
- Knowledge of computer programs, such as Word, Excel, Powerpoint, etc.
- Knowledge of validation.
- Knowledge of documentation and documentation procedures.
- Project management experience.
- Details oriented
- Team player
- Result driven
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GLP (Good Laboratory Practice), Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.