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Vacancy: Quality Assurance Specialist, AstraZeneca, Newark, DE, USA

Vacancy: Quality Assurance Specialist, AstraZeneca, Newark, DE, USA
Posted on: Jul.09.2021

Looking to use your technical degree or QA experience working as a Quality Assurance Specialist in a Pharma/FDA regulated industry? If so, we have an excellent role quality position available that supports the manufacturing and packaging of medicines distributed throughout the world!

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 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.

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 the 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 selected candidate will be a Quality Assurance Specialist in the Site’s Incoming Quality Control team that supports the manufacturing and packaging of medicines distributed throughout the world. In this role, you will be responsible for the inspection and qualification of incoming materials to ensure the availability of raw materials and components including bulk drug products, excipients, packaging materials, etc. The candidate will collaborate with other AZ sites and global QA teams to ensure the quality of incoming materials as well as supporting the Site’s Retain and Product Quality Complaints programs. The candidate will execute ANSI/ISO statistical sampling plans and utilize advanced analytical techniques, including FTIR and Raman spectroscopy, in the inspection process and be flexible to meet the needs of our internal customers.

This is a first shift position Monday – Friday.

This role will be hired at either a Grade C or Grade D depending on the successful candidate's qualifications/capabilities.

What you will do:

* Perform 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.

* Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.

* Work 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.

* Accountable for Supplier Management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI’s.


* Bachelors’ degree, technical degree desired (i.e., Engineering, Chemistry, Biology, etc.) or non-technical Bachelors’ degree with QA experience working in Pharma/FDA regulated industry.
* Excellent oral and written communication skills.
* Strong ability and motivation to learn.
* Capable of working independently.
* Excellent technical writing skills.


Working knowledge of documentation and manufacturing systems such as SAP, TrackWise is preferred. ?

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!

Date Posted: 09-Jul-2021
Closing Date: 25-Jul-2021

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.


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