Manufacturing Specialist - Lead Investigator
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 builds 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.
Everything we do is to make people’s lives better. To us it’s personal, as we invent, make, deliver and support. Taking our cutting-edge innovations from our science labs to patients. Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to shape the next phase of Operations’ evolution and growth. We explore, willing to support new ideas, go above and beyond to find better solutions, every day. This is a place for the resilient – hungry for new challenges and diverse opportunities. The driven – willing to learn, take personal accountability and step out of their comfort zone. To build a collective legacy of doing good for people, the environment and society.
Why Join Operations?
Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.
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 Manufacturing Specialist-Lead Investigator you will lead deviation investigations and CAPA identification; drive adherence to standard work and deviation/CAPA closure.
Initiating, owning, managing, and documenting Critical, Major, and Minor site deviation investigations.
Objectively leading investigative teams of relevant partners to understand breadth, scope, product impact, and root cause(s) of deviations.
Delivering thorough, well documented investigation reports within required timeframes to meet business and compliance needs.
Recommend and facilitate the implementation of CAPA plans, with actions having “line of sight” to the identified root causes, to prevent recurrence.
Collaborating effectively across functions including Manufacturing, Quality, Manufacturing Sciences and Technology, Engineering, and Supply Chain operations focusing on high-quality investigations, corrective action, and reduction of deviations.
Managing multiple ongoing investigations concurrently and present and defend investigations during regulatory inspections.
Performing trend analysis of deviation events and their causes to identify system level actions required to improve the performance of site operations.
Utilizing lean tools, problem solving tools, and human performance tools in the investigations, while developing corrective actions, and the enhancement of site processes and performance.
Applying principles of logic and scientific thinking to a wide range of practical problems while recognizing the need to seek input and / or approval from management.
Guiding site teams and management based on findings resulting from completed investigations and identified trends.
Ensuring alignment of site business processes and goals relevant to the objectives of the deviation management system and the responsibilities of this position.
Essential for the role:
BS/BA degree preferred in engineering, biological sciences or life sciences. Associates and High School acceptable with appropriate experience.
7 years or more of work experience post-bachelor’s degree in GMP manufacturing and / or technical or quality support of GMP operations.
10 years’ experience with Associates degree.
15 years with a High School Diploma.
Excellent organizational, analytical, interpersonal and leadership skills as well as application of problem-solving and root cause analysis tools.
Effective verbal, written, and presentation skills. Ability to analyze data and draw conclusions.
Presence on manufacturing floor to gather data and observe processes is a must.
Strong meeting facilitation, conflict resolution, and negotiation skills. Knowledge of current Good Manufacturing Practices (cGMP's).
Experience with Quality Systems.
Good organizational and project management skills and first-line management skills for daily operation. Solid situational leadership and decision making skills
Working knowledge of Lean Manufacturing, Six Sigma, Human Performance, and other continuous improvement tools and approaches.
Desired for the role:
Lean/Six Sigma certification preferred.
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 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 an excellent fit, please share this posting with them.
Find out more on Social Media:
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.