Senior Specialist, Global Complaint Management
Organon, Gwynedd Valley, Pennsylvania, United States
Senior Specialist, Global Complaint Management
The Senior Specialist, Global Complaint Management plays a key role in the execution of Organon’s global product quality complaint process. This position is responsible for processing complaint handling records, ensuring they are accurately documented and advanced to the appropriate sites or functions for investigation. The role also manages day‑to‑day operations of the complaint sample laboratory, including receipt and logging of complaint samples, oversight of sample evaluations, and coordination of shipments to investigation sites to ensure timely and compliant analysis.
Location: Spring House Innovation Park (SHIP) site, 727 Norristown Road, Building 4, Lower Gwynedd, PA 19002. 2–3 days per week.
Responsibilities
Compile, analyse, and interpret global complaint data, applying statistical process control (SPC) and other analytical tools to support trending, signal detection, and quality reporting.
Manage day‑to‑day operations of the complaint sample laboratory, including sample receipt, logging, evaluation coordination, and shipment of samples to investigation sites.
Process product quality complaint records and advance them to the appropriate sites/functions for investigation.
Ensure accurate and timely entry of complaint data in the electronic complaint system and provide system user support.
Support development and maintenance of SOPs and QMS documents related to complaint handling and system usage.
Prepare complaint data and system information for regulatory inspections.
Partner with IT on complaint system enhancements, issue resolution, and user access, as needed.
Participate in continuous improvement initiatives to strengthen the effectiveness, consistency, and compliance of global complaint‑handling processes.
Required Education, Experience and Skills
BS in a Science or Engineering field or a related discipline.
Minimum of three years’ experience within the pharmaceutical industry.
Strong statistical expertise and previous quality/compliance experience required. Previous complaint experience preferred.
Demonstrated ability to manage time with competing priorities.
Ability to identify and implement continuous improvement principles.
Excellent problem‑solving skills based on science, facts, data and understanding of regulatory requirements.
Ability to persuade others to solve straightforward problems.
Strong interpersonal, communication, collaboration and leadership skills; and ability to work in a diverse environment.
Equal Employment Opportunity Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Travel Required: 10%
Requisition ID: R538794
#J-18808-Ljbffr
Location: Spring House Innovation Park (SHIP) site, 727 Norristown Road, Building 4, Lower Gwynedd, PA 19002. 2–3 days per week.
Responsibilities
Compile, analyse, and interpret global complaint data, applying statistical process control (SPC) and other analytical tools to support trending, signal detection, and quality reporting.
Manage day‑to‑day operations of the complaint sample laboratory, including sample receipt, logging, evaluation coordination, and shipment of samples to investigation sites.
Process product quality complaint records and advance them to the appropriate sites/functions for investigation.
Ensure accurate and timely entry of complaint data in the electronic complaint system and provide system user support.
Support development and maintenance of SOPs and QMS documents related to complaint handling and system usage.
Prepare complaint data and system information for regulatory inspections.
Partner with IT on complaint system enhancements, issue resolution, and user access, as needed.
Participate in continuous improvement initiatives to strengthen the effectiveness, consistency, and compliance of global complaint‑handling processes.
Required Education, Experience and Skills
BS in a Science or Engineering field or a related discipline.
Minimum of three years’ experience within the pharmaceutical industry.
Strong statistical expertise and previous quality/compliance experience required. Previous complaint experience preferred.
Demonstrated ability to manage time with competing priorities.
Ability to identify and implement continuous improvement principles.
Excellent problem‑solving skills based on science, facts, data and understanding of regulatory requirements.
Ability to persuade others to solve straightforward problems.
Strong interpersonal, communication, collaboration and leadership skills; and ability to work in a diverse environment.
Equal Employment Opportunity Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Travel Required: 10%
Requisition ID: R538794
#J-18808-Ljbffr