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 that 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 including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Working Conditions

• Working conditions vary; work may be performed in but is not limited to the aseptic area, mechanical areas, and laboratory.
• Laboratory setting. Will be exposed to bio-hazardous materials, hazardous waste, and pharmaceuticals.
• May require occasional holiday, weekend and/or evening work

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)