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QA Specialist Digital

Requisition ID:  32781
Date:  May 5, 2021
Location: 

Tempe, Arizona, US

Department:  Quality

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

This role is part of the Digital Quality group. This role will support of quality related activities within SAP, West Digital Application, and Manufacturing Execution Systems.  This role interfaces with D&T, Operations, and Quality Assurance for day to day activities and support functions. 

 

Essential Duties and Responsibilities:

  • Creation and Maintenance of quality related data in SAP such as
    • Finished good, raw material and in process material data
    • Certificate profile creation, editing, and support
  • Global item setup in SAP
  • Critical SME to support the facilities for specifications, usage decision, and certificates. 
  • Support the training of employees for the Quality Notification System (Change Control, Events, CAPA, Deviations, OOS) in SAP
  • Perform other responsibilities as assigned to support Digital Quality initiatives
  • Assure compliance to West procedures, regulations and Current Good Manufacturing Practices
  • Support harmonization initiatives as they pertain to the quality management system
  • As appropriate, use knowledge and experience to identify initiatives to improve systems
  • Work independently with limited supervision
  • Act as a resource for colleagues with less experience.

 

Basic Qualifications: 

  • Education or Equivalent Experience: College Degree in Science based subject or
  • Experience: 3-5 years of experience in quality assurance or cGMP manufacturing  

 

Preferred Knowledge, Skills and Abilities:

  • SAP QM
  • Document Management Practices
  • cGMP
  • Comprehend and adhere to the relevant procedures as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times

 

Travel Requirements:

  • Must be able to travel up to 5% of the time

 

Physical & Mental Requirements:

  • Position operates in a professional office environment. May stand or sit for extended periods of time
  • This role routinely uses standard office equipment such as computers, phones, photocopiers
  • Use written and oral communication skills
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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