What are the responsibilities and job description for the Quality Assurance Specialist (second shift) Newark, DE - Operations position at AstraZeneca?
Do you have expertise in and passion for performing Quality Assurance reviews and approvals of the GMP documentation? If so, join AstraZeneca in Newark as a Quality Assurance / Sr. Quality Assurance Specialist, which impacts the Quality organization in a company that follows the science and turns ideas into life-changing medicines.
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.
Our Newark, DE facility is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. The AstraZeneca Newark Supply Site has been voted a Best Places to Work in Delaware and currently employs approximately 260 people. A designated North America Packaging Center of Excellence and Flexible Formulation site for the global supply of complex products, Newark is one of the few locations where it has end-to-end production; they formulate, produce and pack all at one site. It also has a prime location, 35 minutes to Philadelphia, 2 hours to Washington DC, and 2.5 hours to New York! And of course, the Delaware beaches.
The site provides a collaborative environment where everyone feels comfortable and able to be themselves which is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. Newark has a reputation for being one of the friendliest sites in the Americas. It’s hard to walk down the halls without several colleagues asking how you are doing or a friendly hello. 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, teams, site and family activities, dining center, and an approachable leadership team.
This role can be hired as either a Quality Assurance Specialist or Sr. Quality Assurance Specialist depending on the successful candidate's experiences and capabilities. This is a Second Shift position with the working hours of Monday – Thursday (10-hour shifts) from approximately 4:00 PM – 2:30 AM.
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, and regulatory interactions.
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.
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 and demonstrates leadership while working independently with minimal guidance from management.
Training and mentoring of other members of the organization.
Requirement:
Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry, or Engineering with experience working in Quality Assurance in a GMP environment preferred.
Excellent oral and written communication skills.
Strong ability and motivation to learn.
Ability to work shift work
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.
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!
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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.