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Micro Quality Control (Q/C) & Biology Analyst II

North East, MD

Summary

Working with the Director of Microbiology and Biology, organize testing activities to provide accuracy and precision while minimizing workloads. In addition, provide support for laboratory technicians through hands-on training, activity oversight when needed, technician qualification, product validation, and ensuring compliance to GMPs and company guidelines as applicable.

Essential Duties and Responsibilities

Include, but not limited to the following:

· Monitors testing activities based on the testing of Micro QC testing.

· Reviews and updates work schedules to effectively maintain the testing schedule in coordination with management.

· Review testing results to ensure accuracy on reports.

· Coordinates testing plans to ensure materials are tested according to schedules and provides input to management.

· Plan usage of laboratory materials to ensure optimal testing levels.

· Works with management to address issues regarding, testing, product quality and production.

· Manage deadlines based on project expectations for research and testing expectations for microbiology.

· Track production and research and to help predict future scheduling needs.

· Develop and communicate schedule requirements to all affected departments and employees.

· Gathering, processing, analyzing, and sharing research and product test data

· Work with management to establish Standard Operating Procedures (SOP’s) for testing, equipment, and laboratory procedures.

· Work with management to establish test methods, validate products, and qualify technicians to run tests.

· Ensure GMP/GLP equipment under the prevue of the department has undergone calibration and IOPQ (mapping) before previous calibration and IOPQ expires.

· Assist in the acquisition and/or production, if necessary, of research related materials.

· Work with management to design, polish, and enact research procedures.

· Participate in research and/or microbiology testing.

· Analyze and present research data.

· Responsible for the accuracy and completion of GMP testing documentation.

Education and/or Experience

· BS/BA Degree or Certification in microbiology/biology related field or actively progressing towards it.

· Experience with laboratory procedures related to microbiology.

· Three (3) to four (4) years' experience in related field.

· Understanding of USP guidance for testing procedures and FDA regulations for quality assurance work related to test results

· Solid understanding of/experience with MS Office.

· Highly analytical skill set with Excel experience and attention to details.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Regularly required to stand, walk, talk, and hear.

· Required to use hands to finger, handle, or feel and reach with hands and arms.

· Occasionally lift and/or move up to 50 pounds.

· Specific vision abilities required include close, distance, and peripheral vision, depth perception and ability to adjust focus.

Computer Skills

· Requires basic to moderate troubleshooting ability in different computer fields.

· Ability to improve and maintain both physical and computer files, while maintaining GDP standards.

· Understanding of compatibility and reverse compatibility is often necessary.

Other Skills and Abilities

· Leadership and coordination abilities.

· Ability to keep track of multiple tasks that occur simultaneously is needed to effectively oversee the department.

Resume must accompany online application to be considered for this position.