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PQS Audit Specialist- Gaithersburg, MD

Location Gaithersburg, Maryland, United States Job ID R-133943 Date posted 18/04/2022

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 PQS (Pharmaceutical Quality Systems) Audit Specialist in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Responsibilities:

  • Ensure Biopharmaceutical Development sites are always in a state of audit readiness
  • Provide audit/inspection readiness support to Biopharmaceutical Development including site self-inspections and mock inspections
  • Coordinating the review and responses to audit observations and ensuring timely completion of tasks. 
  • Coordinating regulatory surveillance activities and tasks
  • Assist in planning and coordinating Corporate, Customer and Regulatory Agency audits/inspections
  • Assist in developing quality metrics to present to management on a periodic basis (eg. Monthly and Quarterly Management Reviews)
  • Provide support of quality record management in EQV and trending of quality metrics as assigned
  • Responsible for managing AZ Quality & Compliance Manual (QCM) site level implementation and gap assessment process
  • Coordinate and assist in developing Business Process Management (BPM) in Development Quality Biologic and Biopharmaceutical Development
  • May travel nationally/internationally and represent company during audits
  • Assist in improving and maintaining a regulatory surveillance program for Development Quality Biologics organization in support of Biopharmaceutical Development including reviewing regulatory documentation for compliance and coordinating gap assessments as needed
  • Complete routine archive operations for GLP, GCP and GMP paper records generated at the Gaithersburg site(s) under the supervision of archive personnel in accordance with approved procedures as required.


  • BS or BA University degree is required


  • Experience working in a regulated environment:  5+ years with BS/BA degree, 3+ years with MS degree
  • Knowledge of regulatory requirements (eg. 21 CFR Parts 210, 211, 820; EU Volume 4; PIC/S; ICH; ISO; Pharmacopoeia)
  • Experience following standard operating procedures (SOPs)
  • Good listening skills, interpersonal savvy, and peer relations
  • Basic understanding and application of GxP principals, concepts, practices and standards
  • Able to apply and manage risk management philosophy
  • Excellent computer skills, including a high level of comfort with web-based programs in addition to the standard office applications (MS Office, Internet applications, etc.) and understanding of electronic systems such as controlled document/training/compliance systems
  • Ability to transfer knowledge: developing training materials and conveying complex concepts
  • Strong analytical and organizational skills and the flexibility to handle multiple tasks and deadlines
  • Demonstrated experience with regulatory and/or internal audits and inspections

Desired Experience:

  • Experience coordinating audits and site audit readiness activities
  • Experience in production or quality support of Cell Therapy, Device, ADC, Development Labs
  • Experience developing and running metrics
  • Understanding and use of Microsoft Power Platform (Power Automate, Power Apps, Power BI)
  • Understanding and use of LEAN and/or Operational Excellence (FMEA, DMAIC, root cause analysis etc.) concepts
  • Application of risk-based strategy

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 on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

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

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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 authorisation and employment eligibility verification requirements.

10001152 D QAMA Operations

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.