Senior Chemist (Night Shift) - 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.

In the Senior Chemist role, you will perform complex analytical testing for various samples including but not limited to in-process, finished product, stability, raw material, cleaning verification/validation, and development and validation samples. This position is also responsible for participating in laboratory investigations and training other co-workers in QC.

What you'll do

• Performs testing on a range of samples, including chemical raw materials, finished products, stability samples, water, and environmental samples.
• Conduct GMP review of laboratory documentation including review of electronic data in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols. Communicate findings to analysts and follow up on corrections.
• Assist in authoring and finalizing departmental SOPs.
• Evaluates data trends and actively participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents.
• Leads and follows up on ideas for continuous improvements in laboratory processes.
• Maintains and troubleshoots testing equipment.
• Participates in investigations for PET process areas related to QC processes or data.
• Trains QC employees in good analytical techniques, methods and instrumentation based on expertise.
• Actively support the implementation of compendial changes for raw materials, chemical methods or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European, British, and Japanese Pharmacopeia.
• Troubleshoots methods and processes.
• May serve as a specialist in a specific area of laboratory equipment, process, or system and supports regulatory audits.

Minimum Requirements

• Bachelor's degree in chemistry, biology or related field
• Solid understanding of cGXP requirements and a strong familiarity with production operations.
• 3-5 years analytical experience in a pharmaceutical GMP facility using various types of instrumentation (HPLC/GC required, including proficiency with chromatography software such as Empower)
• Proficient in math, laboratory and digital literacy. Understand basic statistics and quality control terminology.
• Working knowledge of laboratory equipment (including HPLC), operations, and safety.
• Knowledge of cGMP and FDA regulations
• Knowledge of 21 CFR requirements for electronic recordkeeping and data integrity
• Excellent attention to details

Preferred

• Self-motivated: able to complete all tasks assigned and self-assign work without immediate supervision, when appropriate.
• Able to knowledgably and safely handle hazardous materials.

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!

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.

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