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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 13307993
Date de publication: 09/13/2019

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 aQuality Control Analyst 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 control testing activities, dependent upon assigned area, including the following:
  • Responsible for conducting raw materials, in process, finished product and stability testing according to standard operating procedures.
  • Completes appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms.
  • Identifies and troubleshoots equipment problems.
  • Enters data evaluated for compliance to specifications and reports abnormalities.
  • Reads, understands, and follows SOP’s and complies with cGMP’s
  • Owns Level 1 Non-conformance records and simple VSCR and CAPA records.
  • Supports preparation of validation protocols, executes experiments, and provides data for validation reports.
  • Responsible for writing new standard operating procedures or revising existing documentation.
  • Applies critical thought to solving problems.
  • Works on problems requiring an in-depth knowledge of scientific methods and techniques.
  • Executes tech transfer and other studies for basic/platform laboratory test methods
  • Performs review of logbooks, chart recorders, etc. across groups
  • 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.

Knowledge:

  • Complete knowledge of the job.  Full understanding of the general and detailed aspects of the job.  Frequent use and application of technical standards, principles, theories, concepts, and techniques associated with specific tasks.

Problem Solving:

  • Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.  Ability to deal with problems involving a few concrete variables in standardized situations.

Freedom To Act:

  • General supervision and instructions given for routine work.  Detailed instructions given for new activities or special assignments.

Impact:

  • Errors can be detected and corrected but may delay lot release.

Interpersonal Communication:

  • Contacts are typically with individuals within own department and occasionally with contacts outside own organization.  Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Education:

  • Bachelors required:  Science/Scientific / Biotech / Pharmaceutical field of study preferred

Experience:

  • 0-5 years of experience in related field.

Note: Selected candidate must be able to work off shift as requested-this could happen occasionally but not on a regular basis.

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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