Aseptic Control Technician- Day Shift- Operations
AstraZeneca

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. As the voice of the patient, every batch we certify is a personal stamp of approval. A place to take Quality seriously - we draw findings from others to develop and understand what it takes to drive our modern approach forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes and Respiratory. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca's priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests.

The Aseptic Control Technician autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting. This position works rotating 12 hour shifts, 6:00AM- 6:00PM.

What you'll do:

• Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Complete required training.
• Perform visual inspections.
• Use MODA to collect and analyze samples.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Perform routine sampling activities and associated data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Provide 24/7 "on-call" support to others.
• Provide feedback on service and quality issues on a timely basis.

Essential for the role:

Minimum Requirements:

• High school graduate, vocational school graduate or equivalent.
• Minimum two years of experience in a pharmaceutical production environment.
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Background:

• Associate or Bachelor's Degree in Science with experience in GMP environment.
• Experience working in Aseptic/Sterile environment.
• Working knowledge of validated digital quality systems such as MODA, Microsoft applications, SAP, KRONOS, and Trackwise.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

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. Interested? Come and join our journey!

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/

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

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