Job Summary
The Sterility Assurance Specialist plays a critical role in delivering expert microbiology and aseptic processing knowledge to bolster the Sterility Assurance and Contamination Control Program. This contract position emphasizes the examination of environmental monitoring reports, personnel assessments, organism trends, microbial contamination inquiries, APS/media fill support, and microbial risk evaluations. The specialist will interpret microbial data and contamination incidents within a comprehensive sterility assurance framework. This role is focused on individual expertise, without managerial duties involved.
Responsibilities
- Deliver technical insights for the assessment of microbial contamination events, including environmental monitoring excursions, personnel monitoring recoveries, and bioburden occurrences.
- Conduct microbiological risk assessments regarding aseptic processes, cleanroom functions, material transfers, and contamination control deficiencies.
- Analyze microbial identification results, supporting the plausibility of organism sources from human flora, water-associated sources, and other environments.
- Assist in the investigation of contamination occurrences across various grades while reviewing relevant data and conditions.
- Collaborate with QC Microbiology and QC EMO to identify concerning trends, recurring organisms, and cross-contamination indicators for necessary escalations.
- Support APS/media fill evaluations by reviewing contamination incidents and intervention effectiveness.
- Help develop risk-based criteria for monitoring trends, microbial identifications, and contamination deviations.
- Review contamination deviations and CAPAs to provide microbiological insights and recommendations.
- Contribute to Sterility Assurance health summaries by evaluating microbial risks and investigation outcomes.
- Aid in creating site standards and technical guidance related to contamination control practices.
Qualifications
- Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, or a closely related field.
- A minimum of 5 years of experience in QC Microbiology, environmental monitoring, or sterile manufacturing support.
- Proficient knowledge in environmental monitoring, microbial identification, and contamination investigations.
- Experience with GMP deviations, CAPAs, risk assessments, and technical documentation.
- Capability to interpret microbial data for effective contamination control solutions.
- Strong communication and technical writing skills across functional teams.
Preferred Qualifications
- Experience in Grade A/B aseptic processes and sterile manufacturing operations.
- Familiarity with APS/media fills, gowning qualification, and disinfectant efficacy.
- Knowledge of regulatory guidelines such as EU GMP Annex 1 and FDA aseptic processing standards.
- Experience with source tracking and investigations related to microbial contamination.
- Collaborative experience with QC Microbiology, Manufacturing, QA, Engineering, and Validation teams.
Core Competencies
- Interpreting microbiological risks.
- Understanding aseptic processing techniques.
- Recognizing patterns and assessing trends.
- Applying root cause analysis methods.
- Competence in technical writing.
- Managing quality risks.
- Applying practical contamination control judgment.
- Influencing as a senior individual contributor.
Hunter Recruiting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
