Quality Microbiologist

Quality Microbiologist

Job Description

Position Purpose:

To apply expertise in microbiology in the operation of the facility's microbiological laboratory, and in

support of sanitary manufacturing. Serves as a microbiology resource for environmental monitoring,

investigation, method transfer/validation, and other special projects as requested.

Customers:

Manufacturing Operations; Microbiology Team; Quality Assurance; Suppliers; Purchasing; Staff and

Global Quality teams; Planning; Logistics/Distribution; Research; Engineering.

General Expectations and Accountabilities:

• Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, to reduce risk and eliminate loss.
• Manages self in accordance with the One K-C behaviors and company values.
• Effectively achieve results that meet business and individual objectives.
• Ensures activities and items are following both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
• Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
• Performs production and quality systems audits.
• Maintain and demonstrate a high degree of knowledge and skill in a product form and quality systems, processes, and regulations.
• Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
• Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.
• Executes continuous improvement activities for established processes and initiates development of new processes.
• Builds and maintains personal capability in QMS, GMPs, and applicable regulation to support objectives.

• Conduct routine Microbiological testing on wet wipes finished product, production materials, environmental samples such as air, surfaces and personnel testing, and water, and specialized testing as required for troubleshooting or as part of an improvement project.

• Conduct all testing and work in conformance with established Good Lab Practices (GLP's) and Good Manufacturing Practices (GMP's).
• Accountable for Micro Team testing, interpretation of results, record management, release of the product. Including raw material testing, Operations GMP audits, monthly GLP audits and
• Good Documentation Practice audits for Micro and Operations Labs, as assigned.
• Accountable for new hire quality training and Microbiology Lab training.
• Prepares and executes Micro Lab test methods transfer, validations and equipment qualifications, as needed. Supports cleaning & sanitization / CIP validations.
• Supports the facility being regulatory audit-ready by maintaining full compliance to procedures, addressing gaps, and facilitating a timely closure to all assigned investigations and problem-solving activities.
• Provides Applied Microbiology technical expertise during investigations of non-conformities.
• Executes assigned continuous improvement activities for established processes and supports development of new processes. Review recommend and update procedures as appropriate.
• Conduct periodic audits of operating areas, sanitization procedures and microbiological laboratory activities to assure conformance to standards and verify effectiveness of training.

• Track, trend, and communicate microbiological data in a timely manner, and in a fashion that compels action.
• Empowered to shut down assets for quality concerns and empowers site colleagues to do the same.
• Function as the back-up for the Micro Laboratory technician as needed.

• The Microbiologist works as a member of the mill Microbiological Laboratory team, applying technical expertise to routine testing, evaluation of data, problem-solving of trends, compliance with applicable procedures and regulation, and support of continuous improvement efforts.
• The Microbiologist takes work direction from the Quality Control Leader. The role is expected to operate with limited direction for day-to-day tasks.

• Bachelor's Degree in Biology, Microbiology, or a related scientific discipline, with at least 2 years of industrial microbiology lab or sanitation experience- including food/dairy, cosmetic/OTC drug, pharmaceutical, or medical device.
• Understanding of Good Lab Practices, environmental monitoring, and trending of data.
• Excellent Microsoft-based computer skills to complete and update detailed specifications and reports, create pivot tables, etc.
• Ability to perform extended microscopic examinations
• Ability to distinguish colors in order to perform analysis
• Must be in good physical condition. Walking, bending, ability to lift up to 40 lbs and able to stand or sit for long periods of time are necessary.
• Ability to understand and follow complex technical instructions
• Excellent verbal and written communication skills
• Must be able to work independently and with a team
• Must be able to work in a fast-paced setting, multi-task and prioritize tasks
• Pays close attention to detail and has strong analytical and organization skills
• Core hours 7 AM to 4:30 PM, with flextime as needed. Must be able to flex to support a 7-day operation, as circumstance dictate.

• 3-5 years Microbiological Lab Experience in regulated product (food, cosmetic, drug device) manufacturing setting, with direct involvement on methods validations, qualification of lab equipment and test methods transfer.
• Demonstrated proficiency with data analysis software, and/or industry-standard systems such as EtQ and SAP Batch management module, LIMS, Minitab or JMP are both statistical software.