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 Document Coordinator 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.

Main Responsibilities:

Scope:

Performs selected quality assurance activities, dependent upon assigned area, including the following:

• 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, SAP, AZDoc and FileTrail.
• Understands basic scientific principles and cGMP. 
• Basic knowledge of functional procedures and routine activities within core area.
• Applies knowledge to recurring, standardized tasks.
• Uses basic analytical skills to develop solutions to task-related problems.
• Escalates/seeks support for more complex problems as appropriate.
• Works under regular and routine supervision following standard procedures. 
• Receives detailed instructions for new assignments.
• Priorities are set by others.
• Work is reviewed for accuracy and completeness.
• Contributes to department goals through quality and efficiency of standard work.
• Contacts are primarily with department peers and supervisor and cross-functionally with peers/supervisors from other internal departments.  Rarely any external contacts.

Core responsibilities include:

• Maintains the document archival room(s) in orderly manner.
• Filing and maintenance of all controlled documents and records.
• Maintain accurate and timely document and record databases and logs.
• Issues production records, logbooks and notebooks for GMP use.
• Scans, verifies and archives documentation and records.
• Prepare records for off-site storage / archive retrieve, return.
• Performs assigned tasks per the schedule
• Maintains training >95% completed on time, with 100% completed prior performing any related tasks
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Education:

• HS diploma or AA degree in relevant area

Experience:

• 0-3 years of experience in biopharmaceutical/pharmaceutical industry.

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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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.