Incoming Quality Control Process Facilitator - Operations
AstraZenecaUs - west chester - ohUpdate time: March 27,2020
Job Description

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.

Brief Job Description

The Incoming Quality Control Process Facilitator is responsible for execution of the incoming quality control activities.  This includes leading a high performing team of technicians working first and second shift.

As a responsible leader for the operation, this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.

As a member of QC leadership, the Incoming Quality Control Process Facilitator will also be responsible for delivering QC and site Quality priorities and initiatives as appropriate, collaborating with supply chain and planning teams to deliver the site priorities.

Job Responsibilities

  • Develop and maintain a high performing team of Technicians
  • Review completed laboratory documentation (for example: log books) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.
  • Train others on procedures, and/or processes.
  • Answer compliance and process questions from others, including regulatory agencies.
  • Communicate policies and procedures to employees.
  • Gather, organize, and communicate operational information to others. Collaborate with PET, Supply Chain and other site colleagues to deliver the site strategic priorities.
  • Lead process improvement activities and teams to meet strategic goals.
  • Communicate priorities and progress to team on a continuing basis.
  • Ensure that employees have the tools needed to perform their jobs safely.
  • Monitor training of employees to ensure compliance.
  • Other duties that support Operations, or Laboratory processes may be assigned.

Competencies

  • Working knowledge of Microsoft applications and other computerized systems
  • Knowledge of cGMPs and global regulatory policies/procedures
  • Basic knowledge of sterile room techniques, chemical handling and usage
  • Basic knowledge of physical, chemical, and microbiological tests in Quality Control
  • Ability to schedule and direct the work of others 
  • Ability to work effectively in a team environment
  • Candidate should possess the ability to work in a changing/demanding environment

Education, Qualifications, Skills and Experience

Minimum Requirements:

  • Bachelor of Science required in Engineering, Pharmacy, related Science or business.
  • Minimum 5 years’ experience in production or quality control environment.
  • Strong communication and leadership skills.
  • Problem solving skills.

Preferred Background:

  • Experience working in a LEAN manufacturing environment
    • Executes the standard process to deliver incoming control activities, on time, in full, in accordance with requirements and in collaboration with other teams.
    • Ensures standard ways of working. Quickly closes out of non-standard practices and conditions or escalates effectively.
    • Identifies and delivers performance improvements to key metrics.
  • Working knowledge of LDMS or AZDocs, Microsoft applications, SAP, Trackwise
  • Training or experience in quality control, validation, technology transfer, change control.
  • Knowledge or previous experience in managing technical programs/projects
  • Strong mechanical, troubleshooting and problem-solving abilities.
  • Ability to direct and participate in cross-functional teams.
  • Project management skills.

Key Relationships to reach solutions

Internal (to AZ or team)

QC staff

PET staff

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.

Date Posted

27-Mar-2020

Closing Date

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 authorization and employment eligibility verification requirements.

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