Microbiologist

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

• Under general supervision, investigates the growth and characteristics of microscopic organisms such as bacteria, algae, and fungi. Designs, conducts, and interprets biological experiments to support development programs and identifies biological pathways and agents.
• Provide biological scientific support to technology and product development. Review scientific and technical summaries and provide recommendations for potential business applications.
• Follow SOPs and special test designs; analyze test data and complete required documentation; initiate and manage QA test method improvements, equipment, and process validations.
• Serve as a team member in the QA Microbiology laboratory ; lead in the implementation of validation and test methods and test correlations.
• Prepare and execute all protocols and reports for validation work.
• Coordinate all validation activities by constant communication with related departments and personnel; oversee and review validation area processes and procedures.
• Responsible for preparing and analyzing timelines and reports to ensure project deliverables arrive on time and within budget.
• Provide day-to-day strategic guidance and direction to Laboratory Technicians regarding validation and process control procedures.
• Maintain strong technical writing skills.
• Clean and maintain laboratory areas and equipment according to procedures.
• Possess laboratory experience and be familiar with basic and advanced scientific principles.
• Follow written directions and maintain a laboratory notebook.
• Update SOPs and Work Instructions as directed; work independently.
• Communicate effectively and be computer literate.
• Perform complex laboratory functions and support studies.
• Document improvements, implement new equipment upgrades and technology.
• Set up, operate, and maintain laboratory instruments ; monitor experiments; record results; develop conclusions.
• Perform all laboratory processes in accordance with cGMPs, SOPs, TMs safety rules, and project schedules.
• Support and coordinate test analysis for Regulatory Affairs, Manufacturing, and R&D departments.
• Perform QC/equipment maintenance; understand lab safety involving potentially infectious bio-waste; be a team player.
• Investigate testing abnormalities; implement non-conformance reporting and corrective actions.
• Perform environmental monitoring testing and support activities in environmentally controlled areas and area expansions.

Qualifications

• Minimum 4-year degree in sciences (preferably Microbiology, Engineering, Chemistry, Biochemistry) with 3-5 years’ experience in Equipment Validation and laboratory techniques within the medical device and/or pharmaceutical industry, or a master's degree in engineering with 2-3 years of relevant experience.
• Familiar with standard concepts, practices, and procedures within the field.
• Technical writing skills are necessary for reports, specifications, and technical documentation.
• Knowledge of GMP, GLP, GDP, FDA, and OSHA regulations is required.