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FDA Quality Compliance Lead - 1st Shift - $22.50

Company: Pitney Bowes
Location: Sparks
Posted on: January 8, 2022

Job Description:

At Pitney Bowes, we do the right thing, the right way. As a member of our team, you can too.
We have amazing people who are the driving force, the inspiration and foundation of our company. Our thriving culture can be broken down into four components: Client. Team. Win. Innovate.We actively look for prospects who:

  • Are passionate about client success.
  • Enjoy collaborating with others.
  • Strive to exceed expectations.
  • Move boldly in the quest for superior and best in market solutions.Job Description:This is a Monday - Friday 1st Shift 9:00 AM - 5:30 PMThis position requires approximately 30% travelYou are:An accountable leader who can work on site to identify and address compliance issues. You are a team player with a strong operations background who will work closely with the GM to ensure facility is operating according to FDA standards.You will:
    • Perform on-the-floor duties including batch record review and oversight of cGMP operators.
    • Log critical customer and consumer complaints.
    • Disposition out-of-spec materials, as directed.
    • Collaborate with other departments such as Inventory, Operations and Account Management to resolve identified issues.
    • Maintain attention to detail while executing multiple tasks.
    • Manage timelines to meet department goals.
    • Maintain control and confidentiality of documents and information.
    • Assist with preparing, reviewing, and controlling documentation required to comply with GMPs, FDA regulations and other regulatory agencies as applicable.
    • Perform QA functions, including copying and scanning of batch records, notification of training needed, and follow up with staff regarding QA signatory and compliance issues.
    • Assist with obtaining documentation necessary for change controls, deviations and other GMP documents.
    • Conduct training classes in a group setting of ten plus.
    • Observe the shipping department to ensure the correct methods are being used when shipping Hazardous Materials.
    • Perform regulatory audits inside and outside of the facility to ensure all requirements are being met per the FDA/DG.
    • Perform the returns process on returns of regulated goods going back into inventory.Your background:As an FDA Quality Compliance Lead, you have:
      • 2+ years of experience in cGMP processing or 21CFR regulations preferred.
      • The ability to use applications such as MS Office Suite, Adobe Acrobat, OneDrive, Excel and MS SharePoint.
      • Critical thinking skills.
      • A strong sense of urgency and commitment to meeting deadlines.
      • Strong detail orientation person who prioritizes being organized.
      • A positive and collaborative work ethic.
      • Effective communication skills and problem-solving skills.
      • Understanding of regulations under 49CFR/Dangerous Goods
      • The ability to develop a strong understanding of regulatory agency requirements applicable to quality operations and compliance.
      • The ability to handle workplace conflict professionally.Our Team:
        Ecommerce logistics. Only easier. Pitney Bowes Global Ecommerce is our fastest growing business segment. Our focus on the consumer and shipper experience - driven by innovative technology and consultative insights - has uniquely positioned us as the trusted partner for ecommerce brands and shippers.Our best-in-class services include ecommerce fulfillment, delivery (domestic and cross-border), and returns that help merchants drive conversions, customer satisfaction and lasting loyalty. These solutions build better order experiences through data science-based innovation and consultative support that help make clients' jobs easier. Ranked by Internet Retailer as a Top Carrier, Top Fulfillment Service Provider, and the #1 International Ecommerce Provider, we are the preferred ecommerce logistics partner for over 800 brands and shippers.We will:
        • Provide the opportunity to grow and develop your career
        • Offer an inclusive environment that encourages diverse perspectives and ideas
        • Deliver challenging and unique opportunities to contribute to the success of a transforming organization
        • Offer comprehensive benefits globally ( Bowes is an Equal Employment Opportunity/Affirmative Action Employer that values diversity and inclusiveness in the workplace.
          Women/Men/Veterans/Individuals with Disabilities/LGBTQ+ are encouraged to apply.
          All interested individuals must apply online. Individuals with disabilities who cannot apply via our online application should refer to the alternate application options via our Individuals with Disabilities link.

Keywords: Pitney Bowes, Sparks , FDA Quality Compliance Lead - 1st Shift - $22.50, Other , Sparks, Nevada

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