QA Advisor - Gaithersburg, MD | Biospace
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QA Advisor

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
United States
Job reference: R-013977

Posted date: Sep. 12, 2017

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 exceptional skills with those of people from all over the globe. As a QA Advisor
in Gaithersburg, MD, 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.

Main Duties and Responsibilities

If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

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 Advisor in Development Quality, you’ll have the opportunity to make a difference in people’s lives every day. We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it.

AstraZeneca is at a critical phase in the journey to deliver our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by 2020, and we have one of the most exciting portfolios in the industry. Development Quality is the organisation that provides the quality oversight for Pharmaceutical Technology and Development (PT&D), the bridge that turns brilliant science into actual medicines that help millions of people, and is responsible for ensuring delivery of investigational medicinal products to clinical trials across the globe.

As a Quality Advisor, you will report to the Director of Quality Assurance and play a pivotal role in quality support and oversight to GMP operations conducted to deliver AstraZeneca and MedImmune clinical trials. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. You will be responsible for review and approval of information provided by internal and external providers, including labelling information, batch and disposition documentation. You will assist client groups in ensuring any deviations and investigations are appropriately investigated and documented and act as Subject Matter Expert supporting internal and external audits and visits to contractor facilities as required.

You will support QA management in ensuring the systems and procedures used by AstraZeneca are fit for purpose and appropriately maintained and identify and implement improvements to AstraZeneca’s systems and procedures. You will ensure practices are conducted in compliance with company policies and site procedures.

Additionally, you will assist in investigations related to non-conformances, vendor reported deviations, trend analyses, and product complaints using Quality Systems tools such as FMEA and Root Cause Analysis. Upon gaining the relevant experience and knowledge of AstraZeneca systems, you will provide Quality and GMP support to CMC project team(s) and assigned projects.


Essential Requirements

  • Appropriate scientific degree with experience (3-5 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organization supporting clinical trials
  • A broad and comprehensive understanding of Quality Systems and GMP
  • A comprehensive understanding of the pharmaceutical/drug development process
  • Experience of working with a team environment.
  • Computer literate (Windows Office/able to pick up new systems quickly).

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.