Job description summary
job description
position title: microbiologist
scope:
performs microbial analysis of finished goods and raw materials. Lead laboratory improvement projects. Assist with training of new technicians. Support sterilization facility routine and validation projects. Perform investigations into out of specifications results.
assure the manufacturing areas are compliant to regulations and gmp and support continuous improvement activities for improved quality and production.
duties and responsibilities:
1. ensures adequate inventory and supply of microbiological materials.
2. performs microbial analysis of finished goods and raw materials.
3. calibration, maintenance and repair of laboratory facilities and equipment.
4. operates laboratory equipment including steam autoclaves, dishwasher, air sampler, particle samples, microscopes, ph meter, balance, madge tech units, spectrometer, and eo experimental vessel.
5. disposes of laboratory waste in compliance with safety and environmental procedures.
6. utilize sap 6.0 to revise and create sops.
7. create and execute protocols to support lab improvement projects.
8. review and approve validation protocols for new processes and improvements/modifications to existing processes.
9. work with day-to-day activities for root cause analysis, corrective action implementation, capa closure and effectiveness review.
10. perform equipment and method validations.
11. conduct and coordinate special projects/requests.
12. write technical reports.
13. support the quality department by performing internal and supplier audits.
14. trained in duties of microbiological technician.
15. work flexible hours as business needs require.
16. actively participate in continuous improvement teams and activities, including 5s, blitzes, shift start-up, updating pvd boards, lean, kas, etc.
17. communicate effectively, timely, and appropriately with all associates including escalating issues.
18. comply with all local, state federal, and bd safety regulations, policies, and procedures including hazardous waste regulations.
19. comply with all local bd quality policies, procedures, and practices through consistent application of sound quality assurance principles.
20. other duties as assigned.
responsible for the documentation, disposition, root cause and corrective action activities of out of spec material.
ensure compliance with all applicable regulations and standards as defined in bd quality, safety and environmental manual and enterprise i.t. systems.
education and experience requirements
• bs degree in microbiology or a related science field, with two years quality experience with emphasis and training in analytical problem solving, lab testing, gmps.
working knowledge of the metric system.
experience with sterilization methods (eto, radiation (gamma), e-beam) - iso 11135, iso 11137.
skills:
* knowledge of lab testing protocols and laboratory experience.
* knowledge of gmp and qsr.
* knowledge of iso requirements.
* familiarity with microbial terminology.
* effective written and oral communication skills (english), math skills, and interpersonal skills.
primary work location
additional locations
work shift
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.
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