Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Quality Sterilization Microbiologist is responsible for coordinating activities to maintain the sterilization assurance program. This includes sterilization cycle reviews, investigation of out-of-specification results, risk assessments, and protocol authorship/execution. Work with sterilization team to support new product development and validation activities.
- Perform analysis of sterilization parameters for product release and sterilization validations.
- Perform investigation of out-of-specification results.
- Evaluate historical data to perform risk assessments.
- Manage EO sterilization requalification and radiation dose audit programs to ensure continuity of validated processes and regulation compliance.
- Coordinate annual and quarterly product re-verifications (Irradiation & Ethylene Oxide).
- Author, execute, or review protocols to support sterilization goals.
- Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).
- Support routine quality control testing of medical device. This may include: bioburden testing, sterility testing, endotoxin testing, enumeration, and environmental monitoring.
- Schedules, conducts, documents, and communicates the results of sterilization and microbiology laboratory tests.
- Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling.
- Communication with customers and team members on product or project status.
- Participate as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives.
- Participate in investigation and summary of results for non-conformance and CAPAs.
- Maintains metrics within sterilization in order to promote continuous improvement.
- Responsible for monitoring reagents and materials to avoid testing delays.
- Assist in training of new employees.
- Ensures that good housekeeping practices are followed in the area and participates in scheduled lab cleaning and maintenance activities.
- Ensures that testing and documentation are performed according to GMP and GDP practices.
- Ability to provide knowledgeable representation during laboratory audits
- Authors and revises SOPs utilizing an SAP document management system.
- Support the quality department by performing internal audits.
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Other duties as assigned.
- Performs testing in a GMP environment
- Timely release of product to support manufacturing and shipping schedules
- Manage laboratory projects in a timely manner to support plant objectives
- Reviews/authors validation protocols and reports for sterilization
- Participate in investigations and summary of results for non-conformance
- Perform residual testing of terminally sterilized medical devices by GC
- Ensures compliance of sterilization and residuals to ISO 11135 and ISO 10993-7
- Bachelor’s Degree in STEM required; microbiology preferred
- Three years relevant experience working in a laboratory environment
- Understanding of GMP laboratory practices
ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS
- Experience with Empower, LabWare, and SAP (preferred).
- Class I / II medical device experience or pharmaceutical experience (preferred).
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA UT - Sandy
Work ShiftUS BD 1st Shift 830am-4pm (United States of America)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory