Principal QA Specialist- 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. 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 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.  

At the Principal level the incumbent will be trained and demonstrate a level of proficiency in all of the Essential Job Functions of the role. The incumbent must demonstrate a strong understanding of the technology area to which the individual is aligned.

What you’ll do:

• Act as quality lead / owner for one or more processes or production areas.  Maintains a high level of understanding of relevant production processes and quality systems.
• Performs the QA review and approval of GMP records that have direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
  • Change Requests
  • Batch Records and associated documentation
  • Product and Component Release transactions in SAP
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • Standard Operating Procedures
• 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
• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders.
• Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported.

Essential for the role:

Minimum Requirements:

• Bachelor’s degree, preferably in a technical field. 
• Minimum of five (5) years of experience in either the pharmaceutical or food industry in an operations management, technical, or Quality Assurance role.
• Strong demonstrated knowledge of cGMPs, Quality Systems, risk management, and pharmaceutical manufacturing.
• Excellent problem solving, interpersonal and oral and written communication skills.

Preferred Background:

• Aseptic / Sterile Manufacturing experience, including fill/finish of parenteral products in RABS or isolator lines. 
• Experience in fill/finish of biological products such as monoclonal antibodies or vaccines
• Experience working in a LEAN manufacturing environment.

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

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.