Quality Assurance Specialist II/ III - Frederick, MD- Operations

Job Description

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’ll do:

As a Quality Assurance Specialist II / III, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The individual assures the quality and compliance of testing for commercial and clinical products manufactured at the facility.

This position is posted as a QA Specialist II or III and hired will be based on experience.

IMPORTANT: This role will be 1st Shift (Monday - Friday, 6am to 2:30pm)

Responsibilities:

Performs selected quality assurance activities, dependent upon assigned area, including the following:

• Reads, understands, and follows SOP’s and complies with cGMP’s.
• Writes new standard operating procedures or revises existing documentation utilizing document management systems.
• Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
• Supports the issuance and reconciliation of GMP documentation
• Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP

Additional responsibilities:

• Reviews documented information from their functional area, reports abnormalities
• Creates/revises QA documents (SOPs, technical reports, risk assessments) in document management system.
• Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS.
• Supports internal audits of manufacturing, analytical testing, labeling to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program
• Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.

Essential for the role:

Quality Assurance Specialist II

• Bachelor's degree; biology, engineering or science-related field preferred
• 2+ years of industry experience
• QA experience preferred

Quality Assurance Specialist III

• Bachelor's degree; biology, engineering or science-related field preferred
• 5+ year of proven experience
• 3+ years of demonstrated ability in QA preferred

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!

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 great fit, please share this posting with them.

Find out more on Social Media:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw