Incoming Quality Control Specialist - Operations
AstraZeneca

Job Info

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Do you have expertise in, and passion for, Quality Control? Would you like to apply your expertise to impact the Quality organization in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the global leading pharmaceutical companies.

Welcome to West Chester, Ohio, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves. This is at the core of AstraZeneca's priorities because it's important to us that you bring your full self to work every day. Onsite amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to Community Outreach, Sustainability, Health and Wellness and Social Events.

As the Incoming Quality Control Specialist, you will be responsible for Quality Control alignment with supply chain and PETs with respect to schedule, prioritization of testing and review, and issue resolution. We work with QC Facilitators on shift to align priorities, local and global teams on supplier complaints and changes, and may act as qualified trainer on incoming sampling and inspection.

What you'll do

• Coordinate workflow, direct priorities and testing schedules for incoming material testing.
• Serves as the primary link between supply chain planners, Packaging QA and QC teams.
• Reviews, verifies and approves IQC data, while monitoring for trends or abnormalities.
• Act as a QC representative for incoming materials for New Product Introduction (NPI) teams, performs change control assessments and act as change owner for IQC processes.
• Supports method qualification and transfer activities for IQC testing.
• Perform and support annual product quality reviews for incoming materials.
• QC lead for investigations involving PET process areas
• Lead vendor certification for incoming materials.
• Trains and mentors IQC technicians on appropriate testing technique associated with incoming material analyses.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Performs project work and leads and author minor IQC investigations, initiate supplier complains.
• Supports site regulatory inspections as an incoming materials subject matter expert.
• Authors, reviews, and approves documents including standard operating procedures (SOPs), protocols, deviations, CAPAs, reports, and other GMP documents as required.

Minimum Requirements

• Bachelor's degree in a scientific or technical field such as Chemistry or Biology.
• 5+ years of experience in the pharmaceutical industry preferred
• Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.

Why AstraZeneca?

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

Next Steps - Apply today!

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