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Senior Quality Control Analyst - Operations

Location Frederick, Maryland, United States Job ID R-054411 Date posted 06/26/2019

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 Senior 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:

The QC Senior Analyst is responsible for the following tasks:

  • Performs broad spectrum of routine tasks in their functional area
  • Reviews documented information from their functional area, reports abnormalities
  • Prepares and executes protocols (including IOQ/PQ as applicable) , authors technical reports, as needed. Interacts, and coordinates with Regulatory, QA and other departments for protocol approval/amendments.
  • Acts as Lead investigator for Level 2 Non-Conformance and OOS and alert investigations. Prepares investigation plan and summary reports.
  • Prepares documentation for presentation to Regulatory Agencies.
  • Applies critical thinking to solving problems of complex scope.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation.
  • Acts independently to develop procedures on new assignments. Assists the implementation of new technology.
  • Assists supervisor by assembling QC metrics as requested for their functional area.
  • Provides direction and training to analysts.
  • Owns QIMS records in Trackwise and DCRs in Aegis.
  • Performs biennial review of and approves process SOPs.
  • Represents Supervisor at meetings, etc as requested and performs selected Supervisor duties as requested.
  • Represents QC on site committees such as EHS, etc.
  • Proposes and implements process, test method and other efficiencies as approved by supervisors/technical specialists.

Knowledge:

  • Complete understanding and wide application of technical principles, theories, and concepts in the field.  General knowledge of other related disciplines.

Problem Solving:

  • Provides solutions to a variety of technical problems of moderate scope and complexity.

Freedom To Act:

  • Works under general supervision.  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:

  • Errors may not be readily detected, but can be corrected; may delay lot release, projects and milestones.

Interpersonal Communication:

  • Primarily internal company contacts.  Infrequent inter-organizational and outside customer contacts on routine matters.
  • Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Education:

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

Experience:

  • Preferred 4+ years of analytical testing experience in pharmaceutical or biopharmaceutical 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.

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

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.