Specialist I, AS&T
Listed on 2026-08-13
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Data Analyst
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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
The Specialist I, AS&T (Analytical Sciences & Technology) is responsible for supporting analytical methods and laboratory systems in a compliant state throughout their lifecycle. The role supports analytical method transfer, verification, and validation activities and contributes to analytical instrument qualification and implementation for GMP use. The Specialist I provides technical support across AST, Quality Control, and Manufacturing Technology functions to ensure compliant, reliable analytical operations.
ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Analytical Methods & Lifecycle Support
- Support transfer of analytical methods, including authoring and executing method transfer, verification, and validation protocols and reports.
- Execute analytical studies, analyze and interpret data, investigate analytical issues, and contribute to effective resolutions.
- Support assessment of method performance and suitability for intended GMP use.
- Technical Writing including SOPs, Protocols, Reports
Instrument Qualification & Laboratory Systems
- Support analytical instrument qualification activities, including authoring User Requirement Specifications (URS), qualification protocols/reports, and executing qualification activities.
- Support implementation and maintenance of laboratory systems in compliance with cGMP/GLP and 21 CFR Part 11 requirements.
- Support site level LIMS activities, including User Acceptance Testing (UAT) and execution of test scripts, as applicable.
Quality Systems & Compliance
- Author and support laboratory investigations, deviations, CAPAs, and change controls related to analytical methods and systems.
- Support maintenance of data integrity and contemporaneous documentation in accordance with GMP expectations.
- Contribute to continuous improvement initiatives within AST laboratory operations.
Cross Functional Support
- Interact with Quality Control, Manufacturing Technology, and other functional groups on technical topics and cross functional projects related to analytical sciences.
- Provide technical support as assigned to ensure timely and compliant project execution.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline with at least 5 years of relevant experience.
- Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, Viral and Cell-based assays, SDS-PAGE, Western Blot, DNA sequencing, microbiological methods, Sterility testing, Endotoxin testing, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.
- Advanced knowledge of USP/EP, cGMPs, 21
CFR part 11, and data integrity with foundational understanding of analytical methods, laboratory instrumentation, and regulated quality systems desirable - Experience in executing phase appropriate method qualifications and validations.
- Experience in assay method validation, equipment validation, and…
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