Quality Control Information Systems / Associate Scientist - Frederick, MD
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.
What you’ll do:
As a Quality Analyst/Scientist you will perform day-to-day administrative activities for Quality Control Information Systems Operations (QCISO), including, end user support, data requests, training, issues resolution of QC computerized systems (LIMS, OpenLab, Empower, and lab computer systems).
Major areas of responsibility may include the following:
• Liaison between QC and Groups across the organization including, but not limited to Validation (CSV), IT (networking and security requirements), Operations IS (enterprise systems), outside vendors (system installation and maintenance), and lab analysts.
• Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
• Prepares and executes protocols (including IOQ/PQ as applicable), authors technical reports, design specs, protocols, as needed.
• Interacts, and coordinates with Regulatory, QA and other departments for protocol approval/amendments
• Acts as lead investigator for Level 2 Non-Conformance. Prepares investigation plan and summary reports.
• Prepares documentation for presentation to Regulatory Agencies.
• Applies critical thinking to solving problems of complex scope.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation.
• Owns QIMS records in Trackwise and DCRs in document change workflows.
• Performs triennial review of and approves process SOPs.
• Represents Supervisor at meetings, etc. as requested and performs selected Supervisor duties as requested.
• Proposes and implements process and other efficiencies as approved by management.
- At least 4 years of Information Management experience
- Bachelors Degree in Scientific / Biotech / Pharmaceutical / IT field of study
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
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.
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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.