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Quality Control Specialist

2 months ago

Chapel Hill, United States SDI International Corp. Full time

Position 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 analyze 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

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, Competencies, and Experience

Three-year experience working in a GMP facility. Salary may be increased for more years of experience.

Position Principal Functions

% Effort

Description

60

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.

15

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.

10

Provide EM testing to support validations as needed.

5

Provide scheduled training to facility employees in regard to best practices around aseptic technique, gowning practices, and cleanroom personnel qualifications.

5

Complete regular cross training on QC testing and provide support to complete testing when the primary QC employee is unavailable.

5

Complete 5 hours of continuous GMP education a year.