Location: Wilmington, DE
Duration: 12 months with possibility of extension or conversion (based on business needs and performance)
Salary: $60-$66 per hour

Job Description
Responsible for Quality Assurance activities that directly support execution of the Quality strategy for the Logistics team within Operations. This includes supporting the establishment and monitoring of the GMP/GDP standards for Logistics, as well as ensuring the standards, quality systems, and processes for Logistics are in line with AstraZeneca and Regulatory requirements. Responsible for supporting adherence with GMP/GDP standards with both internal and external partners, as well as GMP/GDP capability development. Responsible, along with the Global Quality Logistics lead, to establish and support the framework to stay on top of new and changing GMP/GDP requirements and regulations, as well as managing temperature excursions, deviations, complaints, quality agreements, change controls, route risk assessments, and qualification activities related to Logistics.

Typical Accountabilities

• Provides Quality Assurance input into the execution of standardized Logistics processes for managing temperature excursions, complaints, deviations, route risk assessments, quality agreements, and change controls.
  

• Works with PCT team to execute the Global qualification program for Distribution.
  

• Supports New Product Introduction, Acquisitions, Network optimization, Asset Strategy, and/or Value Delivery projects.
  

• Coordinates changes impacting Distribution from within and outside AZ.
  

• Accountable for the Quality Supplier Management and oversight of all global Logistics-related suppliers, including freight forwarders and temperature monitoring providers.
  

• Performs Quality Assurance Technical review/approval of qualification documents, including protocols and reports, as well as Quality review/approval of all Logistics output including, but not limited to change controls, route investigations for Temperature Excursions, Supply and Logistics Complaints, and Route Risk Assessments (RRAs).
  

• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality system.
  

• Collaborates with, and influences, Regional and Global Logistics organization, sites, and functions, to facilitate process improvements and risk assessments; benchmarks internal and external GMP/GDP practices to identify innovative efficient and effective practices.
  

• Accountable for decisions and advises the regional and global Logistics teams, as well as sites and functions on all Logistics-related GMP/GDP issues.
  

• Collaborates in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility.
  

• 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.

Education, Qualifications, Skills and Experience

Essential:

• Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry, or Engineering. A QA professional may be mentored into this role without a degree, based on experience and performance history.
  

• Proven experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance/GMP/GDP role.
  

• Knowledge and understanding of the principles and concepts of GDP, quality and compliance management, quality risk management, and performance evaluation and control.
  

• Excellent oral and written communication skills and an ability to build excellent relationships with stakeholders and customers.
  

• Strong ability and motivation to learn.
  

• Ability to travel nationally and internationally as required, approximately 25% of their time.

Desirable:

• External supplier management.
  

• Lean manufacturing principles, understanding, and experience.
  

• Extensive experience in Good Manufacturing Practices, Good Distribution Practices, and compliance management environment.
  

• Experience of working cross-functionally across the supply chain with groups such as regulatory, Global Compliance Management Group, manufacturing, supply and capability, account management, etc.
  

• Experience working in a PCO/PET organization or Lean/Six Sigma training.
  

• Multi-site / multi-functional experience.
  

• Proven experience in Quality Assurance or combination of Quality and Technical.
  

• Post-graduate qualification.
  

• Qualified Person or equivalent.
  

• Logistics experience.
  

• International experience.
  

• Experience working in Qualification of Logistics solutions.

Benefits

When it comes to working, we want to help take some of life’s pressures off – where we can. So, Kelly employees get access to great benefits, perks, and discounts.

·        EnrollVB Program                

? Teledoc            ? Supplemental Medical              ? Min. Essential Coverage
? Dental              ? Vision                                        ? Legal & Financial
? Accident           ? Short Term Disability                 ? Critical illness

? Term Life          ? Whole Life

 ·        Access 2 Wellness - lower medication costs

·        Kelly’s Life Advisor Wellness Program - access to counselors to assist with a wide range of issues, including Life Coaching sessions

·        Retirement Savings

·        Direct Deposit.  Weekly pay

·        Free skills enhancement and training with More than 6,000 courses and 55,000 eBooks and publications are available

·        Employee Discounts/Perk Spot - Thousands of popular retailers and service providers, you can obtain discounts for almost anything you can buy

·        Holiday and Service plans where applicable

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