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Quality Assurance Senior Specialist - OTF, Philadelphia, PA - Global Operations

Location Philadelphia, Pennsylvania, United States Job ID R-064442 Date posted 10/26/2019

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 Assurance Senior Specialist - On the Floor (OTF) 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 Assurance Senior Specialist (OTF) is responsible for all Quality Assurance (QA) activities that directly support the execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to: batch record review, change control and documentation, equipment and process validation, deviation investigations, SOPs, distribution center management, internal inspections, and regulatory interactions.

Responsibilities:

  • Maintains a high level of understanding of relevant production processes and quality systems
  • Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests, Batch Records and associated documentation, Product and Component, Release transactions, in SAP, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures
  • Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
  • Executes QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives
  • Works with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
  • Collaborates with and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
  • Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
  • Collaborates in data analysis and report creation on quality metrics and key performance indicators 
  • At the senior level, the incumbent will be trained and demonstrate some level of proficiency in all of the major responsibilities of the role.  The incumbent must demonstrate a strong understanding of the technology area to which the individual is aligned.

  • The incumbent will act as an execution lead/process owner for one or more processes.
  • The incumbent must also have consistently demonstrated the following:
  • Strong collaboration between other areas to ensure consistent application of quality systems / processes across the site
  • Ability to work independently with minimal guidance from management
  • Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
  • Demonstrate Target Level 2 Leadership Capabilities with consistent strong demonstration of the four target Skills and Competencies
  • Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported
  • Strong performance history of consistently meeting or exceeding expectations

Qualifications:

Education:

  • Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any bachelor’s degree with a minimum of three (3) years’ experience in the pharmaceutical industry in roles covered by GMP oversight.

Required:

  • Minimum of five (5) years' experience in either the pharmaceutical industry, operations environment or Quality Assurance
  • Ability to work independently under his/her own initiative
  • Aseptic Processing Experience
  • Quality Systems Experience i.e. Deviation Investigation and Root Cause Analysis
  • Strong Knowledge of Data Integrity 
  • Experience with Regulatory Inspections e.g. FDA, MHRA, EMA
  • Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
  • Strong problem-solving skills
  • Excellent oral and written communication skills
  • Strong ability and motivation to learn

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 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.

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