Quality Assurance Specialist II / III
Quality Assurance Specialist II / III- Pharmaceuticals- Gaithersburg, MD
Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients.
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 cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
As a Quality Assurance Specialist II / III, this is an exciting opportunity to be part of the quality oversight of the drug development life cycle process. Utilizing a risk based strategy, you will provide internal and external audits and assess quality at the source utilizing on the floor real time review of batch records and addressing product quality issues and possible non-conformances as they occur.
**This is posted as a Quality Assurance Specialist II / III level position based upon experience**
What you’ll do:
- Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.
- Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.
- Administers the change control and Deviation and corrective action systems for assigned products and quality systems.
- Effectively utilize Operational Excellence tools such as FMEA, DMAIC and root cause analysis.
- Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
- Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.
- Identifies root cause, recommends and implements corrective actions to prevent recurrence.
- Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
Essential for the role:
- Bachelor’s Degree in appropriate scientific field.
- Minimum of three (3) years of working within a GMP environment, preferably within a pharmaceutical development organization.
- A strong understanding of the pharmaceutical/drug development process.
- Previous experience working in Quality within large or small molecules, manufacturing, and lab assays.
- Excellent communication skills with an ability to manage stressful and confrontational situations and move them to positive outcomes.
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.
So, what’s next!
Are you ready to bring new insights and fresh thinking to the table? Wonderful! We have one seat available and we hope it’s yours.
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 phenomenal 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.