Microbiologist
CREMER North America, LP · Cincinnati, OH · 3 wk ago
On-siteInformation TechnologyFull-time
About the role
The Microbiologist position is responsible for the entire CNA microbiology program for raw materials and finished products & processes which specify microbiology requirements. The Microbiologist utilizes critical thinking and attention-to-detail skills to review, monitor, and approve microbiology results to a specific quality standard. As a member of the quality and laboratory team, this position also has specific responsibilities which contribute to the maintenance and improvement of the QA/QC process. Works with all levels of management and associates to facilitate problem solving and ensure customer quality standards are achieved.
Responsibilities
- Owns and is responsible for the Micro Daily Management plan for CNA.
- Reviews & approves all microbiological results for release for all raw materials and finished products that define a micro specification.
- Investigates all micro quality issues, complaints, or aberrant data.
- Provides technical expertise to minimize any potential micro contamination issues and supports production investigations by root cause analysis.
- Serves on the HACCP team as expert microbiologist for risk assessments, critical control point evaluations, and investigations.
- Responsible for the maintenance and improvement of key QA/QC processes with the organization as assigned.
- Sets up and conducts microbiological experiments, sampling, and analyses, using aseptic techniques and methodology.
- Orders and inventories materials to maintain supplies for work.
- Maintains, cleans & sanitizes, or calibrates laboratory instruments or equipment as needed.
- Serves as analytical laboratory back-up support for analyses as needed.
- Serves as support to Corporate Quality for document control, records control, internal auditing, management of change, and other Corporate QA programs.
- In your absence you are to ensure that the tasks assigned to you are adequately covered by trained personnel.
- Communicate and work with your manager to ensure your workload is covered when you are out.
Requirements
- A Microbiology or Biology B.A. or B.S oriented degree or higher in a related discipline or equivalent combination of experience and education.
- 3+ years of progressive experience in a GMP microbiology laboratory or manufacturing environment.
- Experience with microbiological aseptic sampling preferable.
- Experience with EPA, USP or other compendia microbiological methodology preferable.
- Proven attention-to-detail and decision-making skills in a scientific environment.
- Ability to work alone on a task and self-manage time.
Qualifications
- HACCP Membership Responsibilities Selected by management
- Complete a HACCP training course
- Understand and apply the 7 Principles of HAACP
- Maintain a HACCP manual
- Develop, implement, and maintain the HACCP program within CNA for food, cosmetic, and pharmaceutical applications
- React, investigate, and implement corrective actions to any issue that is brought to attention that would impact the quality and safety of the products listed under the HAACP program
- Attend monthly HACCP meetings
- Review Management of Change documents as it relates to the area of expertise within the HAACP team
- Participate as an internal auditor for prerequisite programs and HACCP processes
Skills
- Critical thinking
- Attention-to-detail
- Decision-making
- Microbiology
- Quality assurance
- Manufacturing
- QA/QC process improvement
- Microbial sampling
- Microbial analysis
- Laboratory instrument calibration
- Document control
- Internal auditing
- Management of change
Benefits
N/A
Pay
N/A
Schedule
N/A