Manufacturing Specialist

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 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 exhilarating opportunity to build a long-term, varied career. With a huge variety of global opportunities and team environments, 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 apply now.

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What you'll do:

As a Manufacturing Specialist - Lead Investigator in the Manufacturing group at Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives

Your responsibilities will include:

• Initiating, owning, managing and documenting Critical, Major, and Minor site deviations and major site safety investigations.

• Leading investigative teams of relevant partners to identify breadth, scope, product impact, and root cause(s) of deviations.

• Delivering detailed, well documented investigation reports within required timeframes to meet business and compliance needs.

• Recommending and facilitating the implementation of CAPA plans, with actions having "line of sight" to the identified root causes, to prevent recurrence.

• Collaborating across functions including Manufacturing, Quality, Manufacturing Sciences and Technology, Engineering, and Supply Chain operations and focusing on high-quality investigations, meaningful corrective actions, and reduction of deviations.

• Performing trend analysis of deviation events and their causes to identify system level actions required to improve the performance of site operations.

• Utilizing and promoting the use of lean tools, problem solving tools, and human performance tools in during investigations while developing corrective actions and improving of site processes and performance.

• Owning, reviewing, maintaining, and approving procedures within GMP systems.

Essential for the role:

• BS/BA degree preferred in engineering, biological sciences or life sciences, or equivalent field of study.

• 6+ years or more of experience with Bachelor's degree in GMP manufacturing and / or technical or quality support of GMP operations.

• 10 years' experience with Associates degree.

• 15 years' experience with High School degree.

• Excellent organizational, analytical, interpersonal and leadership skills.

Desired:

• Lean/Six Sigma certification preferred. Solid understanding of Lean Manufacturing, Six Sigma, Human Performance, and other continuous improvement tools and approaches

When we put unexpected teams in the same room, we unleash purposeful thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work the entire shift onsite, bBut that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and evolving world.

Why AstraZeneca?

With constant new products and launches, it's the right time to join our Operations team at AstraZeneca. We are driven by our mission to deliver innovative medicines all the way until they reach our patients. Our resilience helps us thrive as we innovate and evolve in a rapidly changing market. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are driven, take smart risks, and are able to act quickly, we could be the place for you.

Ready to make a big impact? Apply now!

Date Posted

31-May-2024

Closing Date

29-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.