Metrology Manager, GxP QA Manager
AstraZeneca

Job Info

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Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. Working here also means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most groundbreaking technology and lab spaces, all designed to inspire collaboration and multi-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

Summary of the Role:

The Metrology Manager, Quality and vendor led services is responsible for records review and approvals, both digitally and wet signed. They are also responsible for assuring technicians training is up to date, deviation submittals for OPT/OOT conditions, making SOP updates as process gaps are identified, and assisting in vendor send out and on-site calibrations.

Major Duties and Responsibilities:

• Approvals of master GxP calibration records in CMX/SAP after thorough induction work order review is completed.
  
• Approvals of digital GxP calibrations performed in CMX/SAP.
  
• Approvals of digital GxP calibrations performed in IndySoft SaaS calibration manager.
  
• Approvals of hard copy GxP calibration certificates and certifications.
  

Training and SOP Revisions:

• Ensure 100% on-time training completion in CornerStone SBX of all technicians and OSPs.
  
• Assist in a constant improvement team to identify process gaps.
  
• SOP revisions to close CAPAs, define new processes, and close process gaps within the department.
  

On-site/Send-out calibration management:

• Assist in scheduling of send-out and on-site calibrations.
  
• Identifying metrology equipment to be taken out of service if unused or OPT.
  
• Deviation reporting of all OPT standards
  
• Lifecycle management of calibration standards to ensure good business continuity
  

Support:

• Assist less experienced technicians with sophisticated GxP calibrations.
  
• Provide technical support for troubleshooting and resolving system issues, including on-call support as needed.
  
• Assist in calibration performance requirements before less experienced technicians are sent to perform complex calibrations on their own.
  

Team Collaboration:

• Work closely with a team of metrology technicians and managers, providing guidance and support as needed.
  
• Collaborate with team members to ensure 24/7 support and metrology coverage for site operations, lab operations, manufacturing sciences, and quality control.
  

GxP and Non-GxP Operations:

• Ensure calibration management systems support both GxP and Non-GxP operations.
  
• Maintain compliance with regulatory requirements and standards relevant to GxP environments.
  

Sustainability Improvements:

• Identify and implement sustainability initiatives to improve energy efficiency and reduce environmental impact.
  
• Collaborate with internal and external stakeholders to promote sustainable practices.
  

Vendor Management:

• Assist in handling relationships with suppliers and vendors, including negotiating contracts and service agreements.
  
• Evaluate new technologies and products from vendors to determine their potential benefits for the organization.
  

Documentation and Reporting:

• Maintain detailed documentation of system designs, configurations, and maintenance activities.
  
• Prepare and present reports on system performance, project progress, and improvement initiatives to management.
  

Education & Experience Requirements:

• 
  Associate's degree in Engineering, Computer Science and/or military MetCal lab experience and 5 years of experience in metrology and instrumentation, with a strong background in quality control
  
• Experience with SAP.
  
• Proven experience in leading and delivering on time calibrations with minimal OOT impact events.
  

Why AstraZeneca?

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, pioneering groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.

Where can I find out more?

Our Social Media:

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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 authorization and employment eligibility verification requirements.

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