FDA Quality Compliance Lead - 1st Shift - $22.50
Company: Pitney Bowes
Posted on: January 8, 2022
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
- Maintain attention to detail while executing multiple
- Manage timelines to meet department goals.
- Maintain control and confidentiality of documents and
- 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
- 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
- Strong detail orientation person who prioritizes being
- 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
- The ability to handle workplace conflict professionally.Our
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
- 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
(pbprojectliving.com)Pitney 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
Keywords: Pitney Bowes, Sparks , FDA Quality Compliance Lead - 1st Shift - $22.50, Other , Sparks, Nevada
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