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Senior QA Specialist (Pharma Manufacturing)- Operations

Location Frederick, Maryland, United States Job ID R-083618 Date posted 06/30/2020

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.

As a Quality Assurance Specialist IV, you will be in a leadership role at site level. While this role does not have direct reports, you will serve as a mentor to junior and mid-level colleagues in addition to on-the-floor activities. This includes providing day to day direction and training of other QA specialists, as needed.

Our Frederick, MD facility creates life-changing medicines for people around the world! We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

The Frederick Manufacturing Center is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives. We are also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick, and Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019.

**This role is Tuesday-Friday, 2nd Shift (2pm-12:30am) **

Main Responsibilities:

  • Reads, understands, and follows SOP’s and complies with cGMP’s
  • Writes new standard operating procedures or revises existing documentation utilizing document management systems
  • Supports the evaluation and disposition of labelling, 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
  • Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP
  • Reviews documented information from their functional area, reports abnormalities
  • Provides task-oriented training to Specialists.
  • Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
  • Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS 
  • Supports internal audits of manufacturing, analytical testing, labelling to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program
  • Approves reports, investigations and other Quality System records on behalf of QA, as needed
  • Performs risk assessments for variety of processes

Minimum Requirements:

  • Bachelor's degree in Biology, Engineering or Science-related field
  • 7+ year of industry experience
  • Experience in a Pharma/Bio-pharma manufacturing environment


  • 5+ years of on-the-floor QA Experience preferred

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.