Senior Quality Control Analyst

Job description

POSITION OVERVIEW

Data Integrity and Digital QC Laboratory Senior Analyst provides oversight for data integrity and projects related to data integrity. This role also leads and manages the digital activities (e.g. account management, electronic administration activities, etc.) in the laboratory as well as projects related to digital system deployments (e.g. BIOLIMS)

Key responsibilities include but are not limited to:

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Partner with Site Data Integrity Champion on Data Integrity related projects and initiatives

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Provide oversight for the implementation and communication of Regulatory Data  

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Integrity requirements within Allston QC Laboratories

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Coordinate and perform in-process assessments of new systems and periodic inspections with remediation of existing systems.

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Assess systems for gaps or compliance to internal SOPs or industry Data Integrity standards.

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Participate in Data Integrity related investigations and CAPAs

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Support Data Integrity Training and promote a healthy data integrity culture

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Participate in setting or lead the setting of the digital laboratory strategy

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Partner with Site Digital Champion on implementation of digital systems within QC

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Work closely with project groups within the network to ensure successful system implementation meeting site and network needs (e.g. BioLIMS implementation

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Develop and execute strategies to enable digital aspects for inclusion of what is currently a paper-based system

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Collaborate within the organization and externally to enable Best practices and new points for consideration for the digital laboratory strategy

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This position will also be responsible to function as Key User for various QC related systems (e.g. Empower 3, BioLIMS).

Responsibilities as part of the Key User role include:

Site User Support:

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Provide end user support such as system navigation, user administration, instrument connectivity, business process and general application questions.

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Troubleshoot issues before escalating to Support Team

Governance:

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Act as Primary Site Responsible for application and interact with Key Users from other sites.

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May participate in meetings with the Business System Owner (BSO)

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Change Management Submit change requests to ITS in accordance with the application's Change Management procedure.

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Prepare and execute test scripts and assist with the testing of configuration and reports as required.

Communication:

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Be the single point of contact for all application issues and co-ordination of maintenance activities.

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Communicate system outages, changes, and other notifications.

Master Data Management Act as site Subject Matter Expert (SME)

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Responsible for providing site-specific information.

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Maintain specifications, methods, samples, tests and make edits as required using site/business change management process.

Maintain Compliance:

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Compliance with Segregation of Duties requirement and Data Integrity requirements of systems within scope.     

Basic Qualifications

·  Bachelor’s Degree in Science or equivalent with a minimum of 5 years of industry experience or a Master’s degree with 3 years relevant experience
·  Excellent communcation and technical writing skiils
·  Demonstrated problem solving/trouble shooting skills
·  Strong understanding of Data Intergrity Compliance
·  Direct experience working in regulated environments, i.e. cGMP, OSHA and EPA
·  Ability to understand global guidances (ex. USP, ISO, EU)
·  Candidate must be highly organized, flexible and adept to handling multiple project and tight timelines
·  Project management experience a plus

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.