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Schedule: Monday - Friday, 8:00a - 5:00p

Purpose and Scope The Microbiology Sterility Assurance Specialist helps develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications as they relate to sterility assurance. The position supports sterility testing, sterility assurance oversight and contamination control strategies.

Essential Duties & Responsibilities Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate. Provide technical support for all sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed Perform or provide guidance for sterility testing Apply problem solving and quality improvement tools and techniques, including, nonconformance, deviation, preventative and corrective actions and how to overcome barriers to quality improvements Participate in continuous improvement projects to improve quality performance at the site Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends Create, execute, and/or evaluate change controls related to sterility assurance programs Create, execute, review, and/or approve technical documents related to sterility assurance programs Lead or support risk assessments related to sterility assurance programs Lead or provide technical support for root cause investigations related to sterility assurance programs Ensure site's environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level Authoring and maintenance of procedure, policy, and form updates within quality system Evaluation of procedures for compliance and alignment to industry standards Trains, mentors, and develops less experienced colleagues within Sterility Assurance

Knowledge, Skills & Abilities Knowledge of pharmaceutical, food and cosmetic, and clinical microbiology in order to interpret the impact and relative importance of microorganisms when they are isolated from raw materials, component, finished product, water bioburden, equipment and environmental monitoring samples. Demonstrated technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors. Knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting Skill in problem solving. Ability to manage multiple projects concurrently and under tight time constraints. Ability to clearly communicate (verbal & written) and work well with employees at all levels. Ability to be organized and self-directed. Ability to function as a team member and independently. Ability to use specialized computer software such as spreadsheets and graphing software. Mechanical/electrical ability to effect minor instrument repairs is preferred. Advanced skills in math-related processes, with an emphasis on statistics. Ability to fluently and clearly write lab notebooks, reports, and regulatory submissions.

Core Values The Microbiology Sterility Assurance Specialist is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand tha honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline 6 or more years' experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory) Experience with aseptic processing, terminal sterilization and sterility testing preferred.

Working Conditions Laboratory setting and office. Will be exposed to biohazard materials and pharmaceuticals. May require occasional holiday, weekend and/or evening work.

Compensation and Benefits Annual pay range $90,000 - $95,000 Benefits information: https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices