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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 13370118
Date de publication: 10/07/2019

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 Quality Control Associate Scientistin 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:

  • Drives the implementation of new technology.
  • Provides technical guidance and training for lower level personnel
  • Serves as QC interface with MST and ABC/Development/instrument vendors
  • Writes, reviews and approves protocols and reports (e.g. analytical MT, MV and instrument IOQ)
  • Coordinates with lab managers to ensure successful execution of technical protocols, leads investigation of exceptional conditions or atypical data
  • Responsible for on-time delivery of new QC analytical test method and instrument SOPs in support of analytical tech transfer projects
  • Approves new QC analytical test method and instrument SOPs
  • Represents QC on or owns Track Wise records supporting introduction of new analytical technology and new products
  • Serves as lead investigator for non-conformance and OOS and alert investigations of highly technical nature (e.g. require test method history review and possible revision)
  • Assists Sr. Analyst with test method and instrument troubleshooting, review of test methods, SOP review and revision, PQR and regulatory reports etc. as needed                                      
  • Conducts or participates in technically demanding projects within QC

Knowledge:

  • 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.

Problem Solving:

  • 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.

Impact:

  • 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.

Qualifications:

Education:

  • Bachelors required, Advanced Degrees preferred: Science/Scientific / Biotech / Pharmaceutical field of study.

Experience:

  • 6+ years (Bachelor)
  • 3+ years (MS)
  • Strong demonstrated knowledge of cGMPs and Quality Systems in the biopharmaceutical environment.

Preferred:

  • Experience with ELISA (enzyme-linked immunosorbent assays)
  • Experience with Compendial methods
  • Experience with Bioassay

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.

Quality Control Associate Scientist
Qualité

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