Microbiology Coordinator II

Knowledge / Education

• Minimum education required to perform duties: B.S. in Biotechnology, Biology, Microbiology or equivalent.
• Bilingual English/Spanish – Intermediate English level.
• Knowledge on FDA Quality System Regulation, Medical Device Directive, ISO 13485, process validation requirements, biocompatibility evaluation standards and other standards that apply to the design, development and sterilization of medical device.
• Knowledge of GMPs, ISO, USP and FDA regulations as they relate to laboratory operations and investigations and sterilization.
• Knowledge of principles, concepts and methodologies of sterilization processes.
• Certified Internal Quality Auditor is a plus.
• Knowledge and application of statistical techniques (basic descriptive statistics).
• Knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software.

Job Experience

• From 3 to 7 years of work experience within the medical device or pharmaceutical in the monitoring and control of clean room environments field.
• Minimum of 1 year of laboratory management experience.

Skills / Competencies

• Proactive
• Customer oriented
• Diligent
• Ability to work independently and follow both verbal and written instructions

Responsibilities

• Write protocols and reports for Sterilization and/or Microbiological Validation, completes associated paperwork to ensure proper execution (protocol checklists, laboratory submission forms, etc.), interacts with customers as needed

• Elaboration of Validation Master Plans to define / document all the validation strategy required to implement a new product / process or change a current one. Also, elaborate the Validation Master Plan Closure once all the activities have been executed.
• Collaborate in the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
• Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, TMV, OQ and PQ). Prepare respective validation protocols and reports or participate in the approval of them.
• Executes investigations for Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.
• Participate in Internal / External / Customer Quality System audits including all the readiness activities and documents explanation to auditors.
• Manage and lead staff (microbiology technicians) to obtain company goals, including defining and communicating expectations and assignments, monitoring results, coaching, motivating and following up to achieve goals.

• Develop, implement and assure continuance of microbiological testing programs for all critical materials used in engineering, manufacturing and sterile products. Also for medical device sterilization validation programs based on regulatory and customer criteria. 
• Develop microbiological testing criteria and systems for new materials and new products, including material test results for file documentation.
• Develop written procedures to control routine sterilization processing.
• Provide internal consulting to Engineers on new materials and new products to meet material biocompatibility testing requirements.
• Implement various testing programs to assure all materials, the manufacturing environment, environmental control systems and finished products meet all regulatory requirements, including GMP, ISO and Medical Device Directive for sterility and pyrogenicity
• Continuously monitor and evaluate procedures, etc., related to improvements in inefficiencies.  Recommend and, upon approval, develop and implement programs for continual improvement in quality, cost and delivery.
• Develop and perform internal auditing methods as well as audit contract sterilizers and testing labs.
• Direct, evaluate, monitor and review controlled environment microbiological control methods and programs.
• Develop action plans to resolve laboratory issues and microbiological concerns that have the potential to impact product quality.

• Support and assure proper administration of the document control process, including change control and training related to documentation updates.