Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Specialist I, QC is a laboratory position where the primary responsibility is the design of microbiology protocols & reports to support quality control testing, ensuring full compliance with current regulatory standards at all times. The Specialist I, QC maintains strong relationships outside of their own area of expertise and applies broad scope knowledge to support the quality control team in contributing to organizational goals.
- Design and implement protocols and reports for assay development/method suitability and qualification/ validation studies to meet regulatory and ICH guidelines.
- Assess and recommend compendial improvements; lead revisions of existing assays and identify opportunities of new assay development in accordance with internal processes and consistent with compendial and GxP requirements.
- Implement and document environmental monitoring risk assessments to support manufacturing.
- Serve as a subject matter resource for established assays, regulations, and compendia cGMP.
- Lead laboratory investigations and investigation reporting within the microbiology lab and implement corrective actions to address deficiencies.
- Apply technical and scientific expertise cross-functionally to support change and risk management, including the application of scientific and technical innovation.
- Perform validation, technology transfer and troubleshooting, and develop policy procedure for quality initiatives.
- Responsible for the review and interpretation of data, laboratory equipment and records as required to support product release, stability, and validation studies. Prepare process and status reports, and reviews documents for accuracy and completeness, as well as create clear and technically sound reporting for internal and external stakeholders.
- Review microbial identification assays and prepare data trend analyses. Key contributor to the annual report for microbial IDs for the PAR.
- Interpret microbiological cultures and other related tests including but not limited to environmental monitoring, bioburden testing, sterility tests, growth promotion, endotoxin tests, and microbial limits tests/absence-presence testing.
- Manage cross-functional projects ensuring alignment and collaboration, to in turn contribute to the overall business objectives of the organization.
- Identify and champion change through continuous improvement events and initiatives using LEAN practices.
- Contribute to the development of the departmental budget & strategy and provide input on lab requirements and improvements.
- Perform schedule responsibilities to ensure critical QC metrics are consistently accomplished for product turnaround.
- 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.
- 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.
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