Food and Drug Administration Quality Supervisor, 1st Shift (Onsite in Hebron, KY)
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:
oAre passionate about client success.
oEnjoy collaborating with others.
oStrive to exceed expectations.
oMove boldly in the quest for superior and best in market solutions.
Job Description:
We are seeking a Food and Drug Administration (FDA) Quality Supervisor, 1st Shift (Onsite in Hebron, Kentucky).
Your 1st shift schedule will be 8:
00AM - 5:
00PM EST on Monday through Friday.
The work location will be in Hebron, Kentucky with some overlapping supervisor responsibility in Bloomington, California and Greenwood, Indiana.
The wage range for this position is $62000 to $77000, with the actual pay dependent on your skills and experience as they relate to the job requirements and the location where you will be performing the job.
This position is eligible for a quarterly field bonus.
Job
Responsibilities:
Lead internal monitoring and maintenance of documentation and implementation as it applies to new and existing clients.
Lead team of FDA Quality Leads being responsible for maintaining accurate employee records including daily time clock monitoring, coaching, counseling, discipline notification, attendance reports and writing performance reviews for the team.
Interface with presales/ sales/ implementation/ Inventory/ Account Management regarding client's documents and operation compliance on new and existing fulfillment products (SKUs).
Engage other stakeholders as appropriate.
Critical thinker to identify and solve for problematic issues.
Work with appropriate vendors to compliantly disposition out-of-spec materials.
Responsible for preparing, reviewing, and controlling documentation required to comply with our FDA compliance program.
The retention of cMP certifications, client Standard Operating Processes (SOP) Certificate of Analysis (COA), Ingredient Statements, SDS Sheets, and additional documentation when needed.
Detail oriented around detail and familiarity with cGMP requirements as well as 21CFR requirements around dietary supplements/ cosmetics/ holding of pet consumables.
Along with Hazmat shipping requires 49CFR & IATA.
Overseeing new SKU reports for all clients to identify unreviewed SKU's before receiving without documentation.
Reviewing new product safety data sheets to ensure we are registered to house the item and proper shipping.
Advise operations on proper labeling of Hazmat, if required.
Audit Hazmat Access rights within Warehouse Management System (WMS) to ensuring records are current for larger auditing purposes.
This is an internal position with responsibilities to facility leadership report on FDA program violations.
Perform high level regulatory audits inside and outside of all FDA Registered GEC Facilities to ensure all requirements are being met per the regulatory guidelines and report findings to leadership, Senior Compliance and Legal as needed for critical communications.
Log and follow any building maintenance tickets in the event it is an item needing fixed to remain compliant under the 21CFR.
Conduct Root Cause Analysis (RCA) for compliance issues and work with other business units/ departments to resolve.
Ensuring all Pest Control Scopes of Work are meeting GMP regulations and fixing the gap where it is not.
Receiving all documents from each site visit to remain on notice of anything changing.
Perform on-the-floor duties including audits of sanitation, pest control, structural, maintenance and anything else that would impact our cGMP operations.
Skills:
Ability to use applications such as MS Office, Adobe Acrobat, OneDrive, MS SharePoint Critical thinking skills Strong sense of urgency and commitment to meeting deadlines Well-organized and detail oriented Positive and collaborative work ethic Ability to develop strong understanding of regulatory agency requirements applicable to quality operations and compliance.
Qualifications:
Associate degree or technical certification preferred.
5
years relevant experience in cGMP processing / 21CFR regulations We will:
oProvide the opportunity to grow and develop your careeroOffer an inclusive environment that encourages diverse perspectives and ideasoDeliver challenging and unique opportunities to contribute to the success of a transforming organizationoOffer comprehensive benefits globally(PB Live Well)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 Disabilities link.
Recommended Skills Account Management Adobe Acrobat Attention To Detail Auditing Communication Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
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:
oAre passionate about client success.
oEnjoy collaborating with others.
oStrive to exceed expectations.
oMove boldly in the quest for superior and best in market solutions.
Job Description:
We are seeking a Food and Drug Administration (FDA) Quality Supervisor, 1st Shift (Onsite in Hebron, Kentucky).
Your 1st shift schedule will be 8:
00AM - 5:
00PM EST on Monday through Friday.
The work location will be in Hebron, Kentucky with some overlapping supervisor responsibility in Bloomington, California and Greenwood, Indiana.
The wage range for this position is $62000 to $77000, with the actual pay dependent on your skills and experience as they relate to the job requirements and the location where you will be performing the job.
This position is eligible for a quarterly field bonus.
Job
Responsibilities:
Lead internal monitoring and maintenance of documentation and implementation as it applies to new and existing clients.
Lead team of FDA Quality Leads being responsible for maintaining accurate employee records including daily time clock monitoring, coaching, counseling, discipline notification, attendance reports and writing performance reviews for the team.
Interface with presales/ sales/ implementation/ Inventory/ Account Management regarding client's documents and operation compliance on new and existing fulfillment products (SKUs).
Engage other stakeholders as appropriate.
Critical thinker to identify and solve for problematic issues.
Work with appropriate vendors to compliantly disposition out-of-spec materials.
Responsible for preparing, reviewing, and controlling documentation required to comply with our FDA compliance program.
The retention of cMP certifications, client Standard Operating Processes (SOP) Certificate of Analysis (COA), Ingredient Statements, SDS Sheets, and additional documentation when needed.
Detail oriented around detail and familiarity with cGMP requirements as well as 21CFR requirements around dietary supplements/ cosmetics/ holding of pet consumables.
Along with Hazmat shipping requires 49CFR & IATA.
Overseeing new SKU reports for all clients to identify unreviewed SKU's before receiving without documentation.
Reviewing new product safety data sheets to ensure we are registered to house the item and proper shipping.
Advise operations on proper labeling of Hazmat, if required.
Audit Hazmat Access rights within Warehouse Management System (WMS) to ensuring records are current for larger auditing purposes.
This is an internal position with responsibilities to facility leadership report on FDA program violations.
Perform high level regulatory audits inside and outside of all FDA Registered GEC Facilities to ensure all requirements are being met per the regulatory guidelines and report findings to leadership, Senior Compliance and Legal as needed for critical communications.
Log and follow any building maintenance tickets in the event it is an item needing fixed to remain compliant under the 21CFR.
Conduct Root Cause Analysis (RCA) for compliance issues and work with other business units/ departments to resolve.
Ensuring all Pest Control Scopes of Work are meeting GMP regulations and fixing the gap where it is not.
Receiving all documents from each site visit to remain on notice of anything changing.
Perform on-the-floor duties including audits of sanitation, pest control, structural, maintenance and anything else that would impact our cGMP operations.
Skills:
Ability to use applications such as MS Office, Adobe Acrobat, OneDrive, MS SharePoint Critical thinking skills Strong sense of urgency and commitment to meeting deadlines Well-organized and detail oriented Positive and collaborative work ethic Ability to develop strong understanding of regulatory agency requirements applicable to quality operations and compliance.
Qualifications:
Associate degree or technical certification preferred.
5
years relevant experience in cGMP processing / 21CFR regulations We will:
oProvide the opportunity to grow and develop your careeroOffer an inclusive environment that encourages diverse perspectives and ideasoDeliver challenging and unique opportunities to contribute to the success of a transforming organizationoOffer comprehensive benefits globally(PB Live Well)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 Disabilities link.
Recommended Skills Account Management Adobe Acrobat Attention To Detail Auditing Communication Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
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