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Frederick, Maryland, United States
Job reference: R-046058
Posted date: Mar. 04, 2019

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 Control Associate Scientist 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


  • Acts as a subject matter expert for stability program of assigned products.
  • Provides technical guidance and training for lower level personnel
  • Coordinates with BPD during tech transfer to ensure availability of PPQ-enabling deliverables.
  • Coordinates with lab managers to ensure successful execution of stability protocols, leads investigation of exceptional conditions or atypical data
  • Supports stability study design and author protocols in collaboration with key stakeholders including BPD, GTO, QA and RA.
  • Author a variety of stability program reports: quarterly stability data trending reports, stability interim (as needed) and final reports, stability section for PQR.
  • Support all stability data communication to customers (RA, GTO, BPD etc.).
  • Regulatory support (author/co-author relevant regulatory filing sections).
  • Technical support related to Stability (Product Complaint, Deviations, Change Controls).
  • Inspection support for stability questions at FMC and other applicable sites (DP fill sites, etc.).
  • Seek opportunities for continuous improvement, across all aspects of global stability management

Problem Solving/Complexity:

  • Provides technical solutions to a wide range of difficult problems.  Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.

Freedom to Act:

  • Works under general direction.  Follows established procedures to perform job requirements.  No instructions needed on a routine basis. General instructions required to perform new activities or special assignments.  Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.


  • Contributes to the completion of specific programs and projects.  Failure to achieve results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

Interpersonal Communication:

  • Majority of liaison is on internal basis. Liaison normally involves specific phases of a project or operation. 
  • External contacts may be frequent and involve routine matters.

Supervisory/Management Skills:

  • Accomplishes tasks mainly as an individual contributor.  May also provide technical guidance to less experienced staff


  • Bachelor’s degree required.
  • Advanced Degrees preferred in Scientific / Biotech / Pharmaceutical field of study.


  • 6+ years (Bachelor)
  • 3+ years (MS).

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.

Quality Control Associate Scientist - Operations

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