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Our client, a world-leading Pharmaceutical Company in Fort Washington, PA is currently looking for an Transportation Analyst to join their expanding team.
Job Title: Transportation Analyst / Temperature Control / Healthcare Consumer products
Duration: 12 months contract, extendable up to 24 months
Location: Fort Washington, PA
Hybrid work: 2-3 days onsite
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Description:
Job title: Commercial Quality & Compliance Staff Analyst — Fulfillment
Reporting to: Manager Distribution Quality and Compliance CQ BUSINESS QUALITY
Job Description
Overall purpose of job:
The Commercial Q&C Staff Analyst - Fulfillment is responsible to support and execute Quality Management Systems
and compliance with applicable laws and regulations at the Distribution Center that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
Support implementation of departmental strategies and services as the commercial business expert on quality systems, distribution, and quality management. In collaboration with Commercial Quality and other sectors, execute and support common distribution standards and Quality Management Systems (where appropriate) and implements accordingly.
Essential duties and responsibilities:
Key Responsibilities:
Liaise with multiple Quality organizations (Make QA/BQ/Franchise QA) to drive timely resolution of Quality related issues (products and processes).
Support optimization of quality systems and processes aligned with the worldwide business, the quality vision. Support continuous improvement of quality, cost and time factors, consistent with both Sector and Commercial Quality business objectives.
Escalate significant business issues, support action, and support improvement opportunities and problem solutions in collaboration with other Distributions Centers.
Support quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties.
This position will require working closely with various internal and external stakeholders.
Internal: Operations, Franchises and Affiliates
External: Third Party Logistic Partners where applicable
Distribution and Inventory Management Processes
Accountable to support and execution for all distribution and inventory management activities (e.g., receiving, pick, pack, lot reconciliation, reverse distribution, destruction process, quarantine, hold, stop-ship, recall, refusals, donations, destructs authorization, discontinuation, returns, and disposal.
Responsible for ensuring returned product is disposition according to procedures or predefined agreements with
Source Co., Franchise, or Marketing Co.; responsible for resolving discrepancies in a timely fashion with appropriate partner.
Accountable for execution of robust product disposition procedures and the quality oversight of all product quality holds, stock removal, stop ship extension and field actions impacting the Fulfillment operation.
Responsible to support the company's quality and distribution process capabilities against company and industry
standards and regulatory expectations.
Responsible to support for monitoring of calibration and preventive maintenance systems.
Quality Management Systems
Responsible to support the appropriate handling of distribution related customer complaints
Responsible for escalation management to Make QA and Franchise QA as well as commercial business organizations and Deliver operations partners.
Create, review and approve assessment plans, risk assessment reports, non -conformance reports, corrective and preventative actions, audits, and other documentation. Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures.
Support the evaluation of overall compliance risk, Recommend corrective actions and track progress.
Compliance
Support all Health Authority inspections (e.g., FDA) as well as other logistics and transportation related inspections (e.g., TSA, ISO, DEA, DOT and JJRC) conducted.
Understands current and emerging regulations and the impact to quality and distribution practices.
Review and provide guidance to 3PLs on creation and revisions for their procedures, to ensure alignment with Pharmaceutical quality agreements.
Provides interpretation support of policies and regulations to unique site requirements and problems and acts as quality representative for management initiatives.
Support innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost- efficient manner
Special requirements:
10% travel is required.
While perform ing the duties of this job, the employee is regularly required to:
Talk, listen, sit, stand, twist, bend, and walk on a repetitive basis on a concrete floor
Operate a phone, computer, and fax machine
Other features of the job:
Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and/or ISO 13485, 9001:2008, 9001:2015 and/or ERP systems are required. Strong communication, teamwork, problem solving, decision -making, data analysis, inductive reasoning, critical thinking and root cause analysis skills are required. Six Sigma, Lean, SS or ASQ Certification and trainings are preferred. Proficient experience with Excel is required.
Job Requirements
Essential knowledge and skills:
Required
High School
Associates Degree
BA/BS
MA/MS/MBA
Doctorate
Other Certifications
RELATED EXPERIENCE:
0 to 2 years
2 to 4 years
4 to 6 years
6 to 8 years
8 to 10 years
10 years +
A minimum of 6+ years of experience in a highly regulated industry is required. QA/QC experience in the Medical Device, Pharmaceutical, Consumer products or related industry and experience with regulatory inspections is required. DC QA preferred.
Notes from Manager:
Position can be out of Fort Washington (preferred), or Skillman, NJ
Must be able to commute to Fort Washington location
Role will be hybrid after training is done, and the manager feels the candidate can work some days during the week from home (needs to be onsite in the beginning to meet everyone and train)
Role is Quality oversight of Transportation
Must have prior exp with Temperature Control for transportion/freight
They need someone to come in and help maintain the current processes, and keep things moving smoothly
Looking for a problem solver
Product will come in, this candidate will have to determine what correct temperature will be needed for transporting the product
Quality System exp (example, Trackwise, or others)
Quality Management System exp (QMS)
Must have a technical background
Must have the ability to work independently
Overtime will help influence change, or provide solutions to issues that may arise
Our client, a world-leading Pharmaceutical Company in Fort Washington, PA is currently looking for an Transportation Analyst to join their expanding team.
Job Title: Transportation Analyst / Temperature Control / Healthcare Consumer products
Duration: 12 months contract, extendable up to 24 months
Location: Fort Washington, PA
Hybrid work: 2-3 days onsite
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Description:
Job title: Commercial Quality & Compliance Staff Analyst — Fulfillment
Reporting to: Manager Distribution Quality and Compliance CQ BUSINESS QUALITY
Job Description
Overall purpose of job:
The Commercial Q&C Staff Analyst - Fulfillment is responsible to support and execute Quality Management Systems
and compliance with applicable laws and regulations at the Distribution Center that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
Support implementation of departmental strategies and services as the commercial business expert on quality systems, distribution, and quality management. In collaboration with Commercial Quality and other sectors, execute and support common distribution standards and Quality Management Systems (where appropriate) and implements accordingly.
Essential duties and responsibilities:
Key Responsibilities:
Liaise with multiple Quality organizations (Make QA/BQ/Franchise QA) to drive timely resolution of Quality related issues (products and processes).
Support optimization of quality systems and processes aligned with the worldwide business, the quality vision. Support continuous improvement of quality, cost and time factors, consistent with both Sector and Commercial Quality business objectives.
Escalate significant business issues, support action, and support improvement opportunities and problem solutions in collaboration with other Distributions Centers.
Support quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties.
This position will require working closely with various internal and external stakeholders.
Internal: Operations, Franchises and Affiliates
External: Third Party Logistic Partners where applicable
Distribution and Inventory Management Processes
Accountable to support and execution for all distribution and inventory management activities (e.g., receiving, pick, pack, lot reconciliation, reverse distribution, destruction process, quarantine, hold, stop-ship, recall, refusals, donations, destructs authorization, discontinuation, returns, and disposal.
Responsible for ensuring returned product is disposition according to procedures or predefined agreements with
Source Co., Franchise, or Marketing Co.; responsible for resolving discrepancies in a timely fashion with appropriate partner.
Accountable for execution of robust product disposition procedures and the quality oversight of all product quality holds, stock removal, stop ship extension and field actions impacting the Fulfillment operation.
Responsible to support the company's quality and distribution process capabilities against company and industry
standards and regulatory expectations.
Responsible to support for monitoring of calibration and preventive maintenance systems.
Quality Management Systems
Responsible to support the appropriate handling of distribution related customer complaints
Responsible for escalation management to Make QA and Franchise QA as well as commercial business organizations and Deliver operations partners.
Create, review and approve assessment plans, risk assessment reports, non -conformance reports, corrective and preventative actions, audits, and other documentation. Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures.
Support the evaluation of overall compliance risk, Recommend corrective actions and track progress.
Compliance
Support all Health Authority inspections (e.g., FDA) as well as other logistics and transportation related inspections (e.g., TSA, ISO, DEA, DOT and JJRC) conducted.
Understands current and emerging regulations and the impact to quality and distribution practices.
Review and provide guidance to 3PLs on creation and revisions for their procedures, to ensure alignment with Pharmaceutical quality agreements.
Provides interpretation support of policies and regulations to unique site requirements and problems and acts as quality representative for management initiatives.
Support innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost- efficient manner
Special requirements:
10% travel is required.
While perform ing the duties of this job, the employee is regularly required to:
Talk, listen, sit, stand, twist, bend, and walk on a repetitive basis on a concrete floor
Operate a phone, computer, and fax machine
Other features of the job:
Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and/or ISO 13485, 9001:2008, 9001:2015 and/or ERP systems are required. Strong communication, teamwork, problem solving, decision -making, data analysis, inductive reasoning, critical thinking and root cause analysis skills are required. Six Sigma, Lean, SS or ASQ Certification and trainings are preferred. Proficient experience with Excel is required.
Job Requirements
Essential knowledge and skills:
Required
High School
Associates Degree
BA/BS
MA/MS/MBA
Doctorate
Other Certifications
RELATED EXPERIENCE:
0 to 2 years
2 to 4 years
4 to 6 years
6 to 8 years
8 to 10 years
10 years +
A minimum of 6+ years of experience in a highly regulated industry is required. QA/QC experience in the Medical Device, Pharmaceutical, Consumer products or related industry and experience with regulatory inspections is required. DC QA preferred.
Notes from Manager:
Position can be out of Fort Washington (preferred), or Skillman, NJ
Must be able to commute to Fort Washington location
Role will be hybrid after training is done, and the manager feels the candidate can work some days during the week from home (needs to be onsite in the beginning to meet everyone and train)
Role is Quality oversight of Transportation
Must have prior exp with Temperature Control for transportion/freight
They need someone to come in and help maintain the current processes, and keep things moving smoothly
Looking for a problem solver
Product will come in, this candidate will have to determine what correct temperature will be needed for transporting the product
Quality System exp (example, Trackwise, or others)
Quality Management System exp (QMS)
Must have a technical background
Must have the ability to work independently
Overtime will help influence change, or provide solutions to issues that may arise
