Quality Control Specialist – Environmental Monitoring

Job Description

Job Summary:

• The person in this position will be responsible for oversight of the Advanced Cellular Therapeutics Facility environmental monitoring program.
• This person will be responsible to establish a facility environmental monitoring program working with third party vendors as references and developing the appropriate processes to implement a sustainable program at the facility, including the scheduling of environmental monitoring.
• The person will gather data and feedback from stakeholders to create a strategy for environmental monitoring and its execution.
• The role will conduct testing, review results, and analyse the trending of data.
• The person will create and maintain technical documents that support the program and ensure they are followed by educating technicians on aseptic techniques and gowning qualifications.
• The position will track and trend environmental monitoring, investigate environmental occurrences, and assist in review of contamination events.
• Individuals will provide continuous reporting on the status of environment and any developing trends.
• This role will need to work independently with minimum oversight able to identify environmental causes for concern and develop corrective actions to improve processes.

Required Qualifications, Competencies, and Experience:

• GMP (Good Manufacturing Practices).
• Microsoft Office 365.
• 3 years working in GMP facility.
• Knowledge of Microsoft Office software (Word, Excel, Power Point).
• Knowledge of Good Manufacturing Practices and how they are utilized in an academic manufacturing environment.
• Bachelor’s Degree required.

Preferred Qualifications:

• Three-year experience working in a GMP facility.
• Salary may be increased for more years of experience.
• Position Principal Functions.
• 60% Effort.

Implement and maintain Environmental Monitoring (EM) program including but not limited to the following:

• Execute EM Testing in support of manufacturing processes.
• Work with third party vendors to assist in the development of an Environmental Monitoring program.
• Creation of a baseline study to understand the environment of the facility.
• Work with QC Specialist – Equipment to ensure cleanrooms are qualified within the required timeframe.
• Oversee Gowning Qualifications.
• Investigate any EM excursions and develop CAPAs to improve EM results.
• Trend EM results as needed.
• Develop strategy to maintain Environmental Monitoring either within the facility or with the help of 3rd part vendors.
• Work with cleaning team and review environment-cleaning practices and ensure vendor cleaning meets site requirements.
• Schedule EM monitoring of rooms for static and dynamic testing and ensure adherence to schedule.
• Train staff and assess competencies on appropriate aseptic techniques.
• Develop, schedule, and maintain media fill simulations to support clinical activities as needed.
• Assist in the creation, modification and revisions of Policies, Standard Operating Procedures, forms, worksheets, and job aids as applicable.
• Assist in investigations and deviations and completion of Corrective and Preventative Actions (CAPAs) to correct gaps or improve processes and oversee quality improvement projects for environmental monitoring processes.
• Provide EM testing to support validations as needed.
• Provide scheduled training to facility employees in regard to best practices around aseptic technique, gowning practices, and cleanroom personnel qualifications.
• Complete regular cross training on QC testing and provide support to complete testing when the primary QC employee is unavailable.
• Complete 5 hours of continuous GMP education a year.