Requisition Number: 48265
Corning is one of the world's leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people's lives.
Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.
As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning's Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.Scope of Position:
In this role, under the supervision of the Quality Assurance Manager, you will 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. We look for you to develop and validate new and improved microbiological methods. You will 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. You should have the 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.Day to Day Responsibilities:
- 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 mentorship and informative training to manufacturing in the area of microbiological testing and environmental practices.
- Lead, execute and maintain the Sterility Maintenance Program.
- 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 analysis activities in support of resolution of sterility failures, contamination events, etc.
- Maintain accurate and current records of all results and procedures. There needs to a high degree of accuracy in all tests results obtained.
- Coordinate the collection and set-up laboratory test samples according to detailed procedures.
- Lead and supervise the performance of routine preventative maintenance and monitoring of equipment and supplies.
- Performs other tasks as assigned.
- Negligible Hours of work/work schedule/flex-time:
- Standard business hours; Monday - Friday.
- Flex time available.
Required Years and Area of Experience:
- Bachelor's degree in Microbiology or Biochemistry.
- Minimum of 2+ years of experience in industrial microbiology with microbiology testing experience with experience performing work under aseptic conditions.
Desired Experience / Qualifications / Skills:
- 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.
- Proven experience with ISO requirements, GMP (good manufacturing processes) or GLP (good laboratory practices).
- Proficient with Microsoft Office applications.
- Prefer experience in manufacturing industry.
- Chemistry background helpful.
- Knowledge of assay and lab equipment validations.
- Knowledge of documentation and documentation procedures.
- Project management experience.
- Successful working in teams to acquire results by effectively completing assignments with minimal direction required.
- Effective interpersonal skills both written and verbal.
- Must be highly motivated, detail oriented, possess excellent organizational and problem-solving skills
- Must be able to work independently and prioritize and multi-task projects.
This position does not support immigration sponsorship.
We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.