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 Senior Quality Specialist/ Engineer
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, , change control and documentation, equipment and process validation, deviation / CAPA investigations, , supplier management, distribution center quality management, batch release, and regulatory interactions.
At the Senior level you will be trained and demonstrate some level of proficiency in all of the Essential Job Functions of the role. You must demonstrate a strong understanding of the Medical Device Quality Systems/ Combination Products and Packaging technology area to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes.
- Maintains a high level of understanding of relevant production processes and quality systems including ISO-13485 and ISO-14971.
- Provide Quality oversight for assembly and packaging in a fully automated production area understanding Medical Device and Pharmaceutical quality system requirements in this Combination products facility
- Provide leadership, technical expertise & improvements in Quality manufacturing in a Combination products based quality systems, & perform analytical problem solving through sound statistical application.
- 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
- Strong collaboration between other areas to ensure consistent application of quality systems / processes across the site
- Ability to work independently with minimal guidance from management
- Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
- Demonstrate Leadership Capabilities with consistent strong demonstration of the target Skills and Competencies listed below
- Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported
- Strong performance history of consistently meeting or exceeding expectations
- Holds Others Accountable: Holds other accountable for high standards and clarifies what needs to be accomplished, why, and the consequences for the individual and / or the organization
- Bachelor's degree in Engineering or related field
- 5 years' experience in either the medical device or combination products industry or packaging Quality Assurance
- Excellent oral and written communication skills
- Strong ability and motivation to learn
- Strong demonstrated knowledge of Medical Device / Combination Products Quality Systems Strong problem solving and statistical background
- FDA and ISO-13485 knowledge and experience
- CQE (Certified Quality Engineer), CRE (Certified Reliability Engineer), CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor)
- Previous experience with LEAN / Six Sigma Methodologies, process-centric organization with emphasis on continuous improvement
- Experience with new product introduction in assembly packaging environment
- Multi-site / multi-functional experience
- Medical Device / Pharmaceutical experience
- 5 + years experience in Quality Assurance
- Masters Degree in Quality Assurance/Regulatory Affairs
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.