Quality Assurance Specialist / Sr. Quality Assurance Special
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Newark, DE 19713
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/Sr. Quality Assurance Specialist in Newark, DE, you’ll play a pivotal role in channeling 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.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.
This role will be filled as a Quality Assurance Specialist (second shift) or a Sr. Quality Assurance Specialist (first shift) depending on the skills and experience of the successful candidate.
The Quality Assurance Specialist/Sr. Quality Assurance Specialist in Newark, DE directly supports 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.
+ Maintains a high level of understanding of relevant production processes and quality systems
+ Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: 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
+ Works 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
+ Act as process execution lead / process owner for one or more of the following areas:
+ Accountable for Supplier Management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI’s.
+ Accountable for Quality Management of US Distribution Centers.
At this level the incumbent is not necessarily performing all the Major Responsibilities of the role immediately. The incumbent 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 the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
The Sr. Quality Assurance Specialist is responsible for all of the Quality Assurance Specialist tasks to also include:
+ Strong collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site..
+ Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
+ High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
+ Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
+ Training and mentoring of other members of the organization.
+ Strong performance history of consistently meeting and exceeding expectations.
Quality Assurance Specialist:
+ Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelors degree with 3 years experience in pharmaceutical industry in roles covered by GMP oversight.
+ Excellent oral and written communication skills
+ Strong ability and motivation to learn
Sr. Quality Assurance Specialist:
In addition to the above requirements, the following additional requirements apply:
+ Minimum of five (5) years’ experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three (3) years’ experience in Quality Assurance/Compliance.
+ Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
+ Strong familiarity with production operations.
+ Strong leadership, project management, and technical writing.
+ Strong interpersonal, communication, and influencing skills.
+ Minimum of seven (7) years’ experience in QA/Regulatory Compliance in the pharmaceutical industry.
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.