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Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.
Job Summary
Supporting the Microbiology department, The Specialist I, Quality Control is a cross-functional contributor where the primary responsibility is the design of microbiology protocols & reports, managing change controls, CAPAs, investigations, deviations and EM site selection assessments, ensuring timely resolution and continuous improvement. The Specialist I, Quality Control is also responsible for trending and analysis of EM and utility data and is a contamination control strategy SME. They maintain strong relationships outside of their own area of expertise and apply broad scope knowledge to support the quality control microbiology team in contributing to organizational goals.
Responsibilities
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Implement and document environmental monitoring risk assessments to support manufacturing, filling and QC Microbiology.
- Perform environmental monitoring and utility trends for quarterly / annual reports, investigations, audits, etc and provide an assessment and interpretation of results.
- Initiate and author QC Microbiology laboratory investigations and implement corrective actions to address deficiencies.
- Initiate and author QC Microbiology deviation investigations.
- Initiate, author and complete QC Microbiology Change Controls and change actions
- Initiate and complete QC Microbiology Independent CAPA Plans and CAPA actions
- Serve as contamination control strategy SME.
- Provide technical and scientific input to support cross-functional change and risk-management activities, including proposed scientific and technical innovations, in alignment with manager guidance.
- Aid when needed for review and interpretation of data, laboratory equipment and records as required to support product release, stability, and validation studies.
- When needed, provide input for microbial identification assays and prepare data trend analyses.
- When assigned, coordinate cross-functional projects ensuring alignment and collaboration, in consultation with Manager, obtaining approval at key decision points.
- Provide support during internal and external audits, as needed, including preparation, documentation review, data interpretation, and responses to audit requests.
- Maintain current on all regulatory standards and compliance requirements, as well as keep informed of current best practices and opportunities in industry.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- University degree in microbiology, biology or related field of study.
- Minimum of five years of directly related experience in the pharmaceutical/biopharmaceutical industry or related industry.
- Knowledge of statistics would be an asset.
- Comprehensive knowledge of regulatory/industry guidance, pharmaceutical GMPs, laboratory techniques, and standard practice and safety precautions.
- Extensive knowledge of microbial methods (Bioburden testing, membrane filtration, endotoxin analysis, most probable number, familiarity with environmental monitoring and utilities testing, sterility testing, rapid microbiology techniques, techniques for microbiological identification of isolates)
- Demonstrated technical expertise; can perform testing, analyze data and interpret results to make scientifically valid conclusions, as well as lead quality investigations.
- Strong technical and professional communication capabilities; can translate and convey ideas into scientifically sound and efficient risk assessments, study protocols and reports for technical and non-technical audiences.
- Proven leadership abilities, teamwork and collaboration and innovative mindset, accompanied by strong interpersonal, and critical thinking skills.
- Proficient in Microsoft Office - Word, Excel, PowerPoint.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.
