Quality Control Lead Analyst- 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.
Why Join Quality?
In Quality, our work is important and valued. An unrivalled forward-looking mindset, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products – discovery, development and commercialization. As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. A place to take Quality seriously – we draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.
If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you.
What you’ll do:
As a Quality Control Lead Analyst you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing
• Complete documentation per approved procedures; includes reviewing documentation for completeness and accuracy per established timelines and procedures.
• Act as qualified trainer of those with less experience.
• In-direct supervision of lower level personnel.
• Provide input into annual performance evaluations as applicable.
• Investigate and resolve problems. Clear and concise communication to Supervision/Management.
• Coordination of tasks to meet assigned schedule
• Audit support, including presenting information to regulatory agencies, and performing laboratory tours.
• Coordination of projects and project management.
• Develops solutions to complex problems requiring ingenuity and creativity/innovation.
• Ensures solutions are consistent with organization’s objectives
• Work is performed without appreciable direction.
• Contacts are frequent with individuals representing other department, and/or representing outside organizations
• Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation
•Responsible oversight and testing for conducting raw materials, in process, and finished product testing according to standard operating procedures.
• Responsible oversight and performance of utility sampling, environmental monitoring, endotoxin, bioburden, total organic carbon, conductivity testing, subculturing of organisms, growth promotion testing, etc.
•Completes appropriate documentation supporting testing procedures, including data capture forms,
This is a third shift role (2200-0800) hours.
Four days a week (Sunday-Wednesday).
Bachelor’s degree or 4 additional years of work experience in lieu of degree
4+ years of analytical testing experience in pharmaceutical industry
MS Degree: Scientific / biotech / Pharmaceutical field of study.
2+ years of analytical testing experience in pharmaceutical or biopharmaceutical industry.
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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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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.