Quality Assurance Specialist- 2nd Shift- West Chester, OH
Quality Assurance Specialist- Night Shift- West Chester, OH- Operations
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. 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. We are a Combination Products facility encompassing both Pharmaceuticals and Medical Device assembly manufacturing. 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, Medical Device and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes and Respiratory. Our site is one of 26 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.
This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. This position works Monday - Friday from 2:00PM - 10:00PM.
What you’ll do:
- Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
- Participates in risk management process including Process FMEA’s.
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Activities would drive prevention, detection of defects at manufacturing steps
- Maintains a high level of understanding of relevant production processes and quality systems. Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
- Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
- Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
- Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
Essential for the role:
- Bachelor’s degree, preferably in science related field.
- Previous working experience in the pharmaceutical industry or Quality Assurance highly desirable.
- Good problem solving, interpersonal and oral and written communication skills.
- Two (2) years of experience in Quality Assurance.
- Experience working in a LEAN manufacturing environment.
- Knowledge of cGMPs and FDA policies/procedures.
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.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.