Quality Control Associate Scientist

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.

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.

Schedule: Monday-Friday, 1st shift (flexibility in start times: 7-4, 8-5, or 9-6).

Brief

The following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Conducts or participates in technically demanding projects within QC
• Majority of liaison is on internal basis . Liaison normally involves specific phases of a project or operation. External contacts may be frequent and involve routine matters.
• Performs laboratory support.
• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
• Drives the implementation of new technology.
• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
• Contributes to the completion of specific programs and projects. Failure to achieve results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• In addition, for Managers and Project Team Leaders:
• Accomplishes tasks mainly as an individual contributor. May also provide technical guidance to less experienced staff.
• Works under general direction. Follows established procedures to perform job requirements. No instructions needed on a routine basis. General instructions required to perform new activities or special assignments. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
• Provides technical guidance and training for lower level personnel.
• Approves new QC analytical test method and instrument SOPs
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Writes, reviews and approves protocols and reports (e.g. analytical MT, MV and instrument IOQ).
• Typical Accountabilities (per AZ framework and regulatory expectations):
• Manages on-time delivery of new QC analytical test method and instrument SOPs in support of analytical tech transfer projects
• Assists Sr. Analyst with test method and instrument troubleshooting, review of test methods, SOP review and revision, PQR and regulatory reports etc. as needed
• Serves as QC interface with GTO, MS&T, and Development and instrument vendors
• Serves as lead investigator for major deviations and other Quality documents of highly technical nature (e.g. require test method history review and possible revision)
• Represents QC on or owns Quality documents supporting introduction of new analytical technology and new products
• Coordinates with lab managers to ensure successful execution of technical protocols, leads investigation of exceptional conditions or atypical data.

Minimum Requirements

• PhD: Scientific / Biotech / Pharmaceutical field of study, preferred 1+ years of pharmaceutical or biopharmaceutical industry.
• Bachelor’s degree: Scientific / Biotech / Pharmaceutical field of study, preferred 6+ years of pharmaceutical or biopharmaceutical industry.
• Master’s degree: Scientific / Biotech / Pharmaceutical field of study, preferred 2+ years of pharmaceutical or 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, 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 a phenomenal fit, please share this posting with them.