At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Assurance Specialist – Filling (NIGHT SHIFT) in West Chester, OH, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
In this role, you will be working a rotating night shift from 6 pm - 6 am, 2 shifts on, 2 shifts off, 3 shifts on, etc...
As the Quality Assurance (QA) Specialist – Filling (NIGHT SHIFT) you will 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.
Once selected as the QA Specialist, you may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time you will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
- Maintains a high level of understanding of relevant production processes and quality systems
- 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:
- 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
- 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
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Collaborates in data analysis and report creation on quality metrics and key performance indicators
- Bachelors degree in Quality Assurance/Regulatory Affairs or other relevant area
- 5 + years experience in Quality Assurance
- Excellent oral and written communication skills
- Strong ability and motivation to learn
Next Steps – Apply today!
- Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
- Previous experience in a aseptic manufacturing environment
- Multi-site / multi-functional experience
- Masters Degree in Quality Assurance/Regulatory Affairs
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.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.