Quality Assurance Specialist - Operations
AstraZeneca

In Operations, wehave a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.

The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities. It's important to us that you bring your full self to work every day. To help maintain your best self, here's a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.

The QA Specialist/Sr. QA 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, and regulatory interaction.

What you will do:

• 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
  

Career Level Descriptions
The Job Responsibilities provided above represent the full scope of the role. The descriptions below indicate the performance expectations at the different career levels.

QA Specialist
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.

Qualifications:

• Bachelors degree in a Science/Technical field such as Pharmacy, Biology, Chemistry or Engineering preferred
  
• Strong ability and motivation to learn
  

Senior QA Specialist
At this level the incumbent will be trained and able to demonstrate a foundational level of understanding of all the major responsibilities of the role. The incumbent will also demonstrate a high level of proficiency in the primary processes the individual manages.

In addition to this the incumbent must have consistently demonstrated the following:

• 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
  

Qualifications:

• Bachelors degree in a Science/Technical field such as Pharmacy, Biology, Chemistry or Engineering
  
• Five (5) years experience in the pharmaceutical industry and/or FDA experience with 1-3 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.
  

Why AstraZeneca

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what's next

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/
  
• Facebook https://www.facebook.com/astrazenecacareers/
  
• Instagram https://www.instagram.com/astrazeneca/?hl=en
  
• About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
  

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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