LIMS Global AdministratorRemote/Virtual

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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.

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I. JOB SUMMARY

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The Global Administrator QC is accountable for identifying, addressing, and supporting quality control business technology needs.  The administrator will be responsible for planning, coordination, execution and monitoring of activities supporting enterprise (global) computerized systems at Emergent, including infrastructure and software.  As part of the IT team, this role works closely with the quality organization to advocate for the systems and the users through identifying and addressing business needs throughout the software quality lifecycle; selection, analyzing requirements, developing procedures, supporting validation, system monitoring, data migration, production support, issue resolution, archiving, and retirement.  The Global Administrator performs this role for multiple enterprise IT systems, primarily Laboratory Information Management (LIMS) and Chromatography Data Acquisition (CDS) system, with additional touchpoint to integrated systems of SDMS (Scientific Data Management) and Analytics tools.    

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This is a remote/virtual position.

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II. ESSENTIAL FUNCTIONS

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Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

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• Serve as Global Administrator for Emergent’s global Laboratory Information Management System (LIMS), Chromatography Data Acquisition System (CDS), and/or other enterprise Quality systems as required for future capabilities such as SDMS and Northwest Analytics.
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• Subject matter oversight and expertise with a global mindset to identify potential implications of new features and changes to the system and how sites are impacted in terms of system use
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• Maintaining a validated state through managing configuration changes, access, and segregation of duties in global GxP IT systems, including but not limited to
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• Ownership of global standard operating procedures
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• User production support
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• User account administration
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• System configuration
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• Change Request administration
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• Data governance and migration
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• Report and query generation
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• Data export and interpretation of data
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• Database management / validation
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• System troubleshooting
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• Author and collaborate on Change Control, Deviations, and CAPAs
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• Site administrator training
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• Understanding and monitoring adherence to master data standards
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• Collaborate with stakeholders on long-term vision for global systems and provide guidance on project teams to ensure compliant, efficient, and effective business solutions delivery
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• Interpret and apply current Good Manufacturing and Laboratory practices to the continuous improvement of business processes and procedures reflected in computerized systems
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• Work with the quality control organization to identify and implement enabling technology solutions
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• Perform gap assessments and audits of data integrity and computer system validations
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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.

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III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

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• Bachelor’s Degree in biological or computer science
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• Minimum of 5 years of pharmaceutical and / or medical device experience with specific experience applying 21 CFR Part 11 and EU Annex 11 requirements, along with broad working knowledge of other GxP and ISO regulations and guidance
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• Minimum of 6 years implementing and supporting LIMS and CDS systems, with knowledge in LabVantage and Empower solutions preferred
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• Experience with Northwest Analytics, SDMS, and MS SQL Server database queries preferred
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• Quality Control laboratory experience and familiarity with data integrity, acquisition requirements, and knowledge of variety of analytical methods
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• Ability to prepare reports and presentations for executive management and other audiences with a demonstrated ability to clearly communicate complex information  
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• Ability to critically evaluate data summaries and conclusions
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Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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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.

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Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
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Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
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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 ****rel=no-follow>Privacy Policy .
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Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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