Date:
Feb 28, 2014
Location
Fort Washington, PA, US
Johnson & Johnson companies are equal opportunity employers.
COMPLAINTS TRIAGE ANALYST (1 of 2)-1723131113
Description
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
As part of the Complaint Triage, the Complaint Triage Analyst will conduct an initial review of the complaint record in PQMS, make a determination as to whether the complaint requires a site investigation; send the record to the appropriate McNeil site for investigation; and submit records not requiring site investigation to the appropriate Home Office workflow for closure. The Complaint Triage Analyst ensures that the complaint record contains all the required information from the Consumer Care Center prior to sending the record for site investigation or Home Office closure. The Complaint Triage Analyst will also perform change log review and determine the impact to complaint investigation per established SOPs. The Complaint Triage Analyst will interface with the Consumer Care Center and the Office of Consumer Medical Safety to attain any needed clarifications prior to executing any of the complaint triage functions including sending the record for site investigation, or submitting the record for Home Office closure, and change log review.
The Complaint Triage Analyst will verify the validity of the reported product lot numbers using McNeil SAP systems and other business partner interfaces.The Complaint Triage Analyst is responsible for monitoring, prioritizing, and coordinating triage activities related to McNeil products in a timely manner and in compliance with Current Good Manufacturing Practices (cGMP) and McNeil Standard Operating Procedure (SOP) requirements. The Complaint Triage Analyst will partner with other complaint analyst and complaint investigators to ensure thorough, robust, and timely triage of complaint investigations. They will ensure adherence to McNeil, J&J and Regulatory Health Authority Requirements. Execute other functions within the Home Office Complaint Vigilance team as assigned by Complaint Vigilance management.
Qualifications
A minimum of a bachelor's degree is required. A science or technical degree is preferred. A minimum of 3 years experience in a cGMP regulated industry required. Experience in a pharmaceutical manufacturing facility preferred. Previous experience in a quality role within cGMP regulated environment is required. Experience conducting and documenting investigations is preferred. Experience with SAP and product quality management systems such as (PQMS, Etq, Trackwise) is preferred. Demonstrated ability to manage multiple competing priorities is required. Demonstrated ability to work in a fast paced timeline driven environment is required. This position is based in Fort Washington, PA.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Relocation: Eligible No
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: Philadelphia
Job Segment: Medical, ERP, Law, Pharmaceutical, Quality Manager, Healthcare, Technology, Legal, Science, Quality
COMPLAINTS TRIAGE ANALYST (1 of 2)-1723131113
Description
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
As part of the Complaint Triage, the Complaint Triage Analyst will conduct an initial review of the complaint record in PQMS, make a determination as to whether the complaint requires a site investigation; send the record to the appropriate McNeil site for investigation; and submit records not requiring site investigation to the appropriate Home Office workflow for closure. The Complaint Triage Analyst ensures that the complaint record contains all the required information from the Consumer Care Center prior to sending the record for site investigation or Home Office closure. The Complaint Triage Analyst will also perform change log review and determine the impact to complaint investigation per established SOPs. The Complaint Triage Analyst will interface with the Consumer Care Center and the Office of Consumer Medical Safety to attain any needed clarifications prior to executing any of the complaint triage functions including sending the record for site investigation, or submitting the record for Home Office closure, and change log review.
The Complaint Triage Analyst will verify the validity of the reported product lot numbers using McNeil SAP systems and other business partner interfaces.The Complaint Triage Analyst is responsible for monitoring, prioritizing, and coordinating triage activities related to McNeil products in a timely manner and in compliance with Current Good Manufacturing Practices (cGMP) and McNeil Standard Operating Procedure (SOP) requirements. The Complaint Triage Analyst will partner with other complaint analyst and complaint investigators to ensure thorough, robust, and timely triage of complaint investigations. They will ensure adherence to McNeil, J&J and Regulatory Health Authority Requirements. Execute other functions within the Home Office Complaint Vigilance team as assigned by Complaint Vigilance management.
Qualifications
A minimum of a bachelor's degree is required. A science or technical degree is preferred. A minimum of 3 years experience in a cGMP regulated industry required. Experience in a pharmaceutical manufacturing facility preferred. Previous experience in a quality role within cGMP regulated environment is required. Experience conducting and documenting investigations is preferred. Experience with SAP and product quality management systems such as (PQMS, Etq, Trackwise) is preferred. Demonstrated ability to manage multiple competing priorities is required. Demonstrated ability to work in a fast paced timeline driven environment is required. This position is based in Fort Washington, PA.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Relocation: Eligible No
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: Philadelphia
Job Segment: Medical, ERP, Law, Pharmaceutical, Quality Manager, Healthcare, Technology, Legal, Science, Quality
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