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Quality Assurance Specialist IV - 3rd Shift (Pharma Manufacturing) - Operations

Location Frederick, Maryland, United States Job ID R-069264 Date posted 06/11/2020

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 Quality Assurance Specialist IV in Frederick, 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.

While this position is not a supervisory role it, you will be acting in a leadership capacity as a mentor and subject matter expert to other specialists on the team. You will have the opportunity to be involved in training, coaching and delegating occasional job assignments.

This is 3rd shift Night role from Tuesday-Friday

10-hour shift

Hours: 10pm-8:30am

Main Responsibilities:

  • Organizes and leads periodic review of existing QA processes; Writes new SOPs or revises existing documentation utilizing document management systems
  • Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
  • Supports the issuance and reconciliation of GMP documentation
  • Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS
  • Supports internal audits of manufacturing, analytical testing, labeling to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program
  • Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP
  • Represents QA on site committees such as SHE, etc.
  • Approves reports, investigations and other Quality System records on behalf of QA, as needed
  • Performs risk assessments for variety of processes
  • Technical understanding of biotechnology processes.
  • Enhances lean culture through complex problem solving and identification/implementation of improvement opportunities.

Minimum Requirements:

  • Bachelor's degree; biology, engineering or science-related field preferred
  • 5+ years industry experience in biopharma or pharma
  • Ability to make decisions independently and solid leadership skills.

Preferred:

  • 4 years of experience in QA
  • At the source/On floor Operations Manufacturing experience

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 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.

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Glassdoor logo Rated four stars on Glassdoor

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