Quality Assurance Facilitator - Newark, DE - Operations
AstraZeneca

Newark, Delaware

This job has expired.


Do you enjoy working with diverse and collaborative teams within a Pharmaceutical company? If so, this role would be a great fit for you! Put your understanding of cGMP, quality systems, and pharmaceutical manufacturing/packaging technologies to use while also working to bring life-saving medicines to our patients?

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 outstanding skills with those of people from all over the globe.

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 a dining center.

The Quality Facilitator for the Incoming Materials team / PET is responsible for all aspects of the Quality and Compliance of incoming materials used in the manufacturing and packaging of products at the Newark site. This includes manufacturing APIs, raw materials, and excipients, bulk tablets for packaging, and packaging components that require a quality release (bottles, caps, film and foil, labels, cartons/shippers, etc.). This position leads the team of Quality specialists and technicians with responsibility for the sampling, inspection, and release of these materials.

You will partner closely with the Quality Control (QC) team for any incoming materials that require analytical testing, and works closely with the Planning, Formulation, and Packaging PETs to ensure that materials are inspected and released in support of AZ supply chain priorities and 3PS customers and in accordance with all cGMP requirements and expectations.

In this role, you will demonstrate a high-level of Lean / Operational Effectiveness capability to ensure that visual management, problem-solving, and business process owners are robustly embedded within all aspects of the work performed by the team.

The successful candidate will be hired at either a Grade E or Grade F depending on their qualifications.

What you will do:

  • Accountable for all Quality Assurance (QA) activities and decisions (end-to-end) that directly support the execution of the PET mission to include: Batch release, Change control, and documentation, Equipment, and process validation, Deviation investigations, SOPs, and regulatory interactions.


QA Facilitator

Develops and maintains a high level of understanding of the technical production process, equipment, and systems being utilized within the Process Execution Team (PET).
  • Collaborates with counterparts from other sites and functions to ensure consistent application of the key quality systems and continuous improvement of processes.
  • Serves as a liaison with other global AZ supply sites and quality organizations.
  • Participates on internal task forces and may also contribute to external industry associations that evolve and transform the quality assurance discipline
  • Training and mentoring of other members of the organization.
  • A hardworking champion of quality and compliance; maintaining current knowledge of regulatory and industry trends and actively communicating these to colleagues.
  • Leading/driving step-change improvements to quality systems/processes through cross-functional project teams.
  • High level of proficiency in problem-solving and quality risk management principles.
  • A strong performance history of consistently meeting and exceeding expectations.
  • High-level understanding of cGMPs and Quality Systems.


Essentials:

Associate QA Facilitator
  • Bachelor's degree (typically in a science or technical fields such as Pharmacy, Biology, Chemistry or Engineering).
  • Minimum of 5 years of experience in Operations roles within the pharmaceutical industry.
  • Proven understanding of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
  • Prior experience with regulatory agency interactions and compliance procedures.
  • Strong leadership, communication, and influencing skills.


Desired:
  • Prior experience in supervisory/managerial roles
  • Diverse working experience (e.g. multiple sites or functions both within and outside of Quality)
  • Demonstrated Lean / Manufacturing Excellence knowledge and capabilities.


QA Facilitator

In addition to the above requirements, the following additional requirements apply:
  • Minimum of 7 years of demonstrated ability in Operations roles within the pharmaceutical industry.
  • Prior experience in supervisory/managerial roles.
  • Demonstrated Lean / Manufacturing Excellence knowledge and capabilities.
  • Ability to lead strategically and align teams to common goals.


Desired:

  • Expert knowledge of global regulatory and cGMP requirements, industry best practices.


Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us while we continue to build a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we are developing new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our team!

Next Steps - Apply Today!

Curious to know more? Then 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. Know someone who would be an excellent fit? Please share this posting with them.

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


We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.


This job has expired.

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