Sr QC Microbiologist - Kennesaw, GA

Job Description

Senior QC Microbiologist - Kennesaw, GA
This is a full-time, non-exempt position.

Nature & Scope:
The Senior Microbiologist is responsible for ensuring samples from all phases of manufacturing or other handling process are prepared and tested for concentration, presence, and identity of microbial activity. This individual will employ a variety of methods and will require intermediate laboratory skills, as well as a thorough understanding of microbial testing equipment and processes. They will prepare and authorize documentation for the release of raw materials and finished goods and will play an active role in project implementation and documentation. He or she is also responsible for technician proficiency, training, interpretation of methods and results, and minor equipment troubleshooting and repair, they will play a role in preserving workplace safety and safe potentially hazardous materials handling.

Major Accountabilities:
The responsibilities of the Senior Microbiologist include but are not limited to, the following:

Testing and Reporting

• Test submitted samples under cGMP/GLP environment as per company's standard operating procedures and USP/FDA guidelines.
• Assist Lab Administrator with scheduling microbial tests and/or experiments and ensure adequate coverage to meet commitment dates.
• Provide expert opinions and interpretation of microbiological assay results.
• Provide expert opinions and interpretation of OOS results and guide the decision making and documentation process for Laboratory Error Investigations, nonconformances, and deviations.
• Review and approve the interpretation and documentation of results generated by QC microbiologists.
• Ensure microbiological results are appropriately documented and reported in a timely basis.
• Maintain up to date documentation.  Enter all raw data directly into the notebook and promptly calculate all test results.
• Peer review notebooks and test results generated by QC Microbiologists
• Prepare and update COAs as needed
• Maintain laboratory reagents per ISO requirements

Inventory and Equipment

• Ensure reagents, substrates, and kits are prepared according to procedures and are readily available for testing.
• Ensure adequate inventory of lab supplies to conduct microbiological assays while working within the provided budget
• Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up and maintenance.
• Ensure cleaning and use, verification, and maintenance logs are kept up to date and clearly represent the actual history and current status of each piece of equipment.
• Provide input and feedback for design requirements for new and/or replacement equipment
• Schedule and assist equipment repair technicians.
• Assist Laboratory Manager with development of Capex requests.

Training and Proficiency

• Develop and execute training plan for QC Microbiologists on methods and technique.
• Oversee and schedule laboratory proficiency testing as required by ISO 17025 standards.
• Ensure QC Microbiologists are appropriately trained on all assays for which they are scheduled
• Determine the proficiency status of QC Microbiologist.

Method Optimization and Validation

• Review validation results and investigate non-conforming values.
• Optimize methods and investigate matrix interferences for documentation of exemptions
• Oversee implementation of new methods
• Conduct and determine uncertainty measurements as required by ISO 17025.
• Submit change control requests for methods or procedures that need to be added, revised, or updated to ensure equipment and methods are performed in a manner to minimize uncertainty and variability.
• Review and provide feedback on standard operating procedures, forms, and documents.

Management

• Lead microbiology department with effective mentoring, directing and coordination of development activities
• Communicate and enforce laboratory quality requirements to personnel working in the lab and ensure that they are completed per GMP, GLP and ISO 17025 standards
• Lead and facilitate initial and periodic training of QC Microbiologists to ensure standard laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards (21 CFR, §11, §111 and §117, ISO17025 and the requirements of TGA PIC/s)
• Assist with preparation and delivery of personnel evaluations and competencies.
• Assist with improvement plans/disciplinary action where necessary
• Coordinate objec