Sterility Assurance Specialist

GSK•Marietta, PA

4d•Onsite

About The Position

As a Sterility Assurance Specialist, you will be Subject Matter Expert (SME) for development, implementation, monitoring and improvement of Sterility Assurance Programs at the Marietta Site location. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Responsible for improving sterility assurance program at Marietta and sharing sterility assurance best practices between Marietta and other GSK aseptic manufacturing sites. Evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements. Lead, develop, implement, influence changes to meet requirements and continuously improve sterility assurance processes. Responsible for aseptic process simulations, facility cleaning, material transfer, aseptic behavior, Environmental Monitoring, gowning and contamination control strategy programs. Provide oversight and measure effectiveness of Sterility Assurance programs. Maintain and improve LSOPs (local procedures) for these programs and perform periodic review of local procedures (for example- facility cleaning, aseptic behaviors, material transfer, gowning, EM and aseptic simulations). Responsible for trending, generating Environmental Monitoring trend reports and ensuring that Environmental Monitoring and gowning programs are in control. Responsible for all rationale documents and risk assessments to support the environmental monitoring and gown monitoring programs. Provide expert advice when changes to classified environments are proposed to evaluate the benefits or disadvantages of the proposed changes and to assist with investigation of excursions. Provide trending data analysis to assist with the evaluation of the impact of excursions. Ensure that the site monitoring strategy for classified areas complies to procedures and external regulatory expectations. Interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics. Participate in the investigation and planned remedial actions for out of compliance EM / Sterility Assurance results in order to support the timely resolution of investigations. Own and execute quality system (CAPA, Change Control, LSOP revisions, gap analysis). Responsible for training, coaching, and qualification program for aseptic techniques, clean room behaviors, and gowning. Provide technical guidance for all questions and issues related to sterility assurance topics and support 3 shifts of operation, as required. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Requirements

Bachelor’s degree in microbiology, biology, pharmacy, or related scientific discipline.
5+ years pharmaceutical industry experience.
Experience in a GMP/Microbiology/Quality or Aseptic Area role to include direct work with environmental monitoring of aseptic filling operations and sterility assurance systems.
Technical expertise in sterility assurance process, environmental monitoring and gown monitoring programs.
Knowledge of microbiology, contamination control programs to implement and improve cleaning, gowning, aseptic behaviors, material transfer, aseptic simulations and environmental monitoring programs.
Experience leading investigations, deviations, or microbiological problem solving.
Ability to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.

Nice To Haves

Master’s degree in biology or microbiology, pharmaceutical sciences, or related field.
Advanced practical knowledge of aseptic process simulations, cleaning, gowning, aseptic behaviors, material transfer and environmental monitoring programs required to influence decision making, regulators and stakeholders.
Experience supporting regulatory inspections and preparing regulatory responses.
Knowledge of sterility assurance principles, USP chapters, and cleanroom standards.
Experience with aseptic process validation and gowning practice oversight.
Familiarity with electronic quality management systems for investigations and CAPAs.
Strong technical writing skills to produce clear, audit-ready documentation.
Ability to work collaboratively and escalate issues when needed.
Ability to champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the site.
The ability to drive site objectives and results; work in a fluid environment; drive culture & lead department initiatives.
Demonstrated interpersonal and leadership skills.
The ability to function and influence within a team-based organization.

Responsibilities

Improving sterility assurance program at Marietta and sharing sterility assurance best practices between Marietta and other GSK aseptic manufacturing sites.
Evaluating manufacturing operational practices and strategies to ensure compliance with regulatory requirements.
Leading, developing, implementing, and influencing changes to meet requirements and continuously improve sterility assurance processes.
Overseeing aseptic process simulations, facility cleaning, material transfer, aseptic behavior, Environmental Monitoring, gowning, and contamination control strategy programs.
Providing oversight and measuring the effectiveness of Sterility Assurance programs.
Maintaining and improving LSOPs (local procedures) for these programs and performing periodic review of local procedures.
Trending and generating Environmental Monitoring trend reports and ensuring that Environmental Monitoring and gowning programs are in control.
Developing all rationale documents and risk assessments to support the environmental monitoring and gown monitoring programs.
Providing expert advice when changes to classified environments are proposed to evaluate the benefits or disadvantages of the proposed changes and to assist with investigation of excursions.
Providing trending data analysis to assist with the evaluation of the impact of excursions.
Ensuring that the site monitoring strategy for classified areas complies with procedures and external regulatory expectations.
Interfacing directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics.
Participating in the investigation and planned remedial actions for out of compliance EM / Sterility Assurance results to support the timely resolution of investigations.
Owning and executing quality system processes (CAPA, Change Control, LSOP revisions, gap analysis).
Responsible for training, coaching, and qualification program for aseptic techniques, clean room behaviors, and gowning.
Providing technical guidance for all questions and issues related to sterility assurance topics and supporting 3 shifts of operation, as required.
Performing all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.