Quality Assurance Specialist
3 weeks ago
Job Summary
BD is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our products and processes.
Key Responsibilities
- Coordinate the activities of the Microbiology Laboratory in support of a 24/7 shift manufacturing operation.
- Supervise the monitoring of inventory of items in the microbiology lab.
- Perform procedures, validation, and training according to Good Manufacturing Practices (GMP) and Corporate Quality Assurance.
- Perform laboratory owned calibrations.
- Understand the principles of scheduling and how it relates to the support the Sterility Assurance Program.
- Schedule and perform non-routine testing as needed.
- Perform out of specification investigations.
- Back up for approving the sterilization dose data with the Senior Microbiologist.
- Coordinate and direct the incubator temperature profiles and the annual laboratory autoclave requalification.
- Assist with the development and documentation associated with new procedures including the development of preventative maintenance programs as needed.
- Responsible for purchasing supplies and maintaining the monthly budget.
- Oversee the training of new associates or the implementation of a new process in the lab.
- Ability to operate all equipment / perform all testing in the lab with basic trouble shooting skills.
- Perform Lab Technician functions as directed or needed.
Requirements
- Bachelor of Science or Arts degree in a scientific field, with a minimum of four courses in microbiology related field- OR - an equivalent level of training, experience, and demonstrated proficiency in understanding and interpreting critical sterilization and microbiological data (minimum of 2 years) is required.
- Familiarity and experience with aseptic technique is required.
- Familiarity with regulatory environments is preferred.
- Knowledge of GMP and other regulatory requirements is preferred.
- Familiarity with moist heat and/or gamma irradiation sterilization modalities preferred.
About BD
BD is one of the largest global medical technology companies in the world. We are committed to advancing the world of health by improving medical discovery, diagnostics, and delivery of care. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
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