Sr. QC 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 will do:

Perform selected quality control testing activities, dependent upon assigned area, including the following:

• Responsible for conducting testing, which may include raw materials, in process, drug substance, drug product, and stability testing according to standard operating procedures.
• General supervision and instructions given for routine work.  Detailed instructions given for new activities or special assignments.
• Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
• Reads, understands, and follows standard operating procedures.  Responsible for writing new standard operating procedures or revising existing documentation.
• Completes appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms.
• Enters data evaluated for compliance to specifications and reports abnormalities.
• Performs review of data capture forms, logbooks, chart recorders, etc. across groups
• Follows all safety regulations as indicated in AstraZeneca Policies and Procedures.  Adheres to Company safety procedures and guidelines on a daily basis.
• Maintains training
• Calibrates and maintains laboratory equipment according to standard operating procedures.  Maintains lab instrumentation according to maintenance schedules.
• Identifies and troubleshoots equipment problems.
• Owns minor deviation, change control, and CAPA records.
• Supports preparation of validation protocols, executes experiments, and provides data for validation reports. Executes tech transfer and other studies for basic/platform laboratory test methods.
• Applies critical thought to solving problems.  Works on problems requiring an in-depth knowledge of scientific methods and techniques.

Requirements:

Be able to plan and carry out laboratory operations efficiently and effectively. Be able to maintain accurate records of all experiments and data. Critical thinking and attention to details required. Must be a team player and customer oriented. Candidate will be working under supervision but level of independence should increase with time.  QC or GMP experience a plus.

Self-motivated. Multi-tasking, excellent written and oral communication skills desired.

Education:

Sr. QC Analyst

BS/MS in biological or chemical science or engineering (chemistry, biochemistry, chemical engineering, etc.).

BS (4+ years) preferably in biopharmaceutical industry.

MS (3+ years) preferably in biopharmaceutical industry.

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, 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!

Date Posted

Closing Date

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.