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 QA Specialist / Engineer (Night Shift)
in West Chester, OH
, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities You will be 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 CAPA investigations, supplier management, distribution center quality interaction.
You will specialize in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs in this Combination Products facility. 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 in Medical Devices and Pharmaceutical industries.
- 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:
- AQL Sampling and training
- 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
- 2 years' experience in either the medical device or pharmaceutical industry, an operations environment or Quality Assurance
- Ability to work 12 hour night shift and every other weekend
- Excellent oral and written communication skills
- Strong ability and motivation to learn
- Bachelor's degree in Engineering or related field
- Previous experience with LEAN / Six Sigma Methodologies with emphasis on continuous improvement
- Medical Device experience preferred
- Multi-site / multi-functional experience
- 5 + years experience in Quality Assurance
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.
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.