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Quality Control Analyst III - Philadelphia, PA - Global Operations

Location: Philadelphia, Pennsylvania, United States
Job reference: R-060931
Posted date: 09/11/2019

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Control Analyst III in Philadelphia, PA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Quality Control Analyst III is responsible for conducting routine and non-routine analysis of environmental samples, raw materials and in process samples according to standard operating procedures. Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.

Job responsibilities include but are not limited to:

  • Calibrates and maintains laboratory equipment according to standard operating procedures.
  • Reviews data obtained for compliance to specifications and reports abnormalities.
  • Executes validation protocols, laboratory test plans, and reports results to management.
  • Prepares documentation for presentation to Regulatory Agencies.
  • Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
  • Prepares validation protocols, executes experiments, and prepares validation reports.
  • Responsible for writing new standard operating procedures or revising existing documentation.
  • Applies critical thought to solving problems of complex scope.
  • Works on complex problems requiring an in-depth knowledge of scientific methods and techniques.
  • Acts independently to determine methods and procedures on new assignments.
  • Prepares investigation reports.
  • Prepares documentation for presentation to Regulatory Agencies.
  • Works on extremely complex problems where analysis of situations or data requires an in-depth evaluation of intangible factors.
  • Creates schedules of laboratory activities, train and coach other QC Analysts.
  • 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.
  • Key relationships to reach solutions Internal (to AZ or team) External (to AZ)

Qualifications:

Education:

  • Bachelor’s Degree Microbiology or related discipline.

Required:

  • Minimum of three (3) years of experience working in regulated QC laboratory.
  • Previous GMP experience.
  • Experience with methods and systems used in QC laboratory.
  • Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
  • Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
  • Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
  • Computer Skills: Microsoft Outlook, Explorer, Excel, Word, PowerPoint




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 authorisation and employment eligibility verification requirements.