QA Specialist / Sr. QA Specialist
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a QA Specialist/Sr. QA 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.
Brief Job Description
Responsible for 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.
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:
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
(USBC) 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.
QA Specialist Role
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.
Senior QA Specialist Role
At the senior level the incumbent will be trained and demonstrate some level of proficiency in all of the major responsibilities of the role. The incumbent must demonstrate a strong understanding of the technology area to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes.
The incumbent must also have consistently demonstrated the following:
• 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 Target Level 2 Leadership Capabilities with consistent strong demonstration of the four 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
Education, Qualifications, Skills and Experience
QA Specialist Role:
• 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
Senior QA Specialist Role:
• 5 years experience in either the pharmaceutical industry, an operations environment or Quality Assurance
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
• Strong problem solving skills
Ability to work independently under his/her own initiative.
This position will be hired at either a QA Specialist Role (C) or a Senior QA Specialist Role (D).
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:
MedImmune is the global biologics research and development arm of AstraZeneca