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QC Senior Analyst -Frederick, MD

Lieu Frederick, Maryland, États-Unis Job ID R-140267 Date de publication 06/15/2022

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Our Frederick Manufacturing Center (FMC) is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It’s challenging but highly rewarding work, involves more than 675 talented people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

We are dedicated to creating a culture of inclusion and collaboration. We are committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.

Main Duties and Responsibilities

Scope

  • Perform day-to-day activities of QC computerized systems, such as LIMS, OpenLab, Empower, and lab computer systems
  • Perform application administration tasks for QC computerized systems
  • Liaison between QC and the Validation group with relation to software/computer system validation
  • Liaison between QC and IT to administrate all software/computer applications and fulfill all networking and security requirements
  • Liaison between QC and Operation IS in maintaining LIMS, OpenLab, and other enterprise systems
  • Facilitate and coordinate training of new and existing LIMS users, prepare training materials as necessary
  • Creates and manages deviations, change controls, and CAPAs related to QC computerized systems.
  • Work with Operation IS to implement changes to corporate systems such as LIMS, OpenLab, etc.
  • Create/Maintain SOPs related to QC information systems
  • Manage QC system interface with other MedImmune enterprise systems such as SAP

Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement

Essential Requirements

Experience & Education

Bachelors:  Scientific / Biotech / Pharmaceutical / IT field of study, 4+ years information management experience.

Desirable Requirements

Impact

  • Errors may not be readily detected, but can be corrected; may delay lot release, projects and milestones.

Freedom to Act

  • Works under limited supervision. 
  • Follows established procedures to perform job requirements. 
  • No instructions needed on a routine basis.
  • General instructions required to perform new activities or special assignments. 
  • Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Knowledge

  • Complete understanding and wide application of technical principles, theories, and concepts in the field. 
  • General knowledge of other related disciplines.

Problem Solving

  • Provides solutions to a variety of technical problems of moderate scope and complexity.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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