Scientist Microbiology Quality Control - Lewisville, TX

Job Details

Type: Temp to Hire

Pay Rate: Up to $40/hour

Location: Lewisville, TX

Schedule: M-F Hours 8-5 with 1 weekend per month rotation working Saturday and Sunday a few hours each day in the morning.

Job Summary

Ensures that microbiological quality standards are consistently met and product integrity is maintained for susceptible materials, component parts, equipment, facilities, and other items which affect product manufacturing systems and processes. Supports departmental goals by coordinating and/or performing lab activities to ensure timely support for supply chain needs and/or meeting project deadlines. Partners with operations and other quality groups to ensure microbiological risk consideration in facility, equipment, and system design and implementation. Applies technical knowledge globally in collaborative response to microbial contamination issues, aberrant test results, environmental excursions, systems development and validation, and root cause analysis.

Experience

• Experience: Minimum of 3 years related work experience.
• Supervisory Experience: Not specified.
• Education: Bachelor's degree in Microbiology or Biology or equivalent with a minimum of 3 years related work experience or an Associate degree (or 16 hrs. college level science courses) and 6 years experience in a laboratory environment.

Responsibilities

• Core duties and responsibilities may be generally aligned with either Quality Control Testing activities or Environmental Monitoring and Cleaning Validation processes. Cross-functional awareness is expected, and some tasks may have cross-functional relevance and application.
• Recognize contamination potential and inconsistent or out-of-specification results or trends. Responsible for timely communication to customer groups and Quality management in the event of aberrant test results.
• Ensure all quantities of affected materials or items are accounted for and appropriately locked or held to prevent use or sale until compliance is determined.
• Ensure timely response to Global Inventory and Supply Chain business needs including verbal and written communications and timely disposition of approved materials.
• Coordinate and provide support for daily activities in the Quality Control Microbiology lab including Microbial Content Testing, Rapid Method Tests, Media Preparation, and all related tasks.
• Provide technical support for advanced skills and ensure timely testing of all raw materials, process water, bulk products, finished products, and components that require Micro testing.
• Monitor reporting systems to ensure appropriate disposition timing, observe for missed samples, and for incomplete data.
• Perform GMP review and approval of all QC Micro sample data and media/supply production records ensuring all data and records are complete and accurate.
• Serve as an interface with customer groups and contract & raw material vendors to facilitate reporting of test results and resolve concerns over Microbial Content Test specification requirements or test procedures.
• Research, perform, and document validation support studies following defined procedures. Perform non-standard testing and analysis to respond to identified microbial quality needs.
• Evaluate and validate current microbiological methods, procedures, and practices to ensure effectiveness and compliance.
• Use thorough foundation in microbiological principles to collaborate in the development of new processes, methods, and technology.
• Support the Micro Environmental Audit program and execute environmental audit processes and facility inspections.
• Support contamination investigations by gathering crucial equipment, material, batch, and test documentation and/or performing critical control point testing.
• Coordinate and perform Cleaning Validation studies and participate in internal System Audits of manufacturing operations.
• Participate on global facilities, engineering, quality, and product or equipment-related project teams to ensure Microbial Quality standards and concerns are considered from design through implementation.
• Apply knowledge and understanding of RO Water system and USP water standards to help ensure micro integrity of the RO Process Water System.
• Document all data and results accurately and perform data trend analysis.
• Assist in preparation of SOPs, methods, etc. as required. Review Operations SOPs, OPLs, WIs, etc. for acceptable compliance to Micro standards.
• Possess matured microbiological judgment to recognize microbial quality risk as well as inconsistent, concerning, or failing results or trends.
• Provide technical support for advanced microbiological skills and perform diversified and complex microbiological tasks as needed.
• May supervise, lead, and train nonexempt technicians or Assistant Scientists.
• Manage or oversee laboratory supply purchases and equipment maintenance; provide input to budget processes.
• Perform miscellaneous laboratory duties such as general cleaning, supply management, and waste management.
• Perform and document departmental training, intra-departmental cross-training, micro orientation training, micro hygiene awareness training, laboratory safety training, and other Micro/GMP-related training as needed.
• This job requires on-site work.