Specialist, Quality Assurance
Position Overview: (Basic Functions & Essential function(s) includes, but is not limited to:
- Responsible for executing relevant procedures to ensure Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes are in compliance with regulatory expectations.
- Responsible for receipt, processing, and follow-up of Product Quality Complaints or Adverse Event Quality Investigation Requests.
- Acts as an effective liaison between Organon support functions worldwide for complaint-handling activities to ensure regulatory compliance is maintained.
- Provides expertise on complaint-handling processes and systems to resolve issues and drive continuous improvement..
Main Activities: (Primary activities include, but are not limited to):
- Ensures accurate, consistent, and timely entry and assignment of Product Quality Complaints and/or Adverse Event Quality Investigation Requests into electronic tracking system.
- Acts as an effective liaison between Organon Designated Point of Contacts, Complaint Handling Units, Lead Complaint Investigating Sites (LCIUs), Business Partners, Pharmacovigilance, Quality, Legal, etc. for complaint-handling activities to ensure regulatory compliance is maintained.
- Performs PQC/AE-QIR complaint-handling activities including but not limited to reconciliation, follow-ups, customer/business partner responses, second person review, and complaint closure activities, when required.
- Performs sample follow-up with Designated Point of Contacts, as needed.
- Processes, documents, and prepares returned complaint samples for shipment to investigating sites. Performs functional sample testing, when designated by LCIU and documents all findings in the complaint records.
- Perform ad hoc and routine data analysis, including the compilation and presentation of metrics to leadership.
- Perform second-person review functions for various quality activities.
- Authors consumer and Health Authority responses to Product Quality Complaints.
- Develops and updates standard operating procedures for area to ensure consistent processes among team and drive continuous improvement.
- May lead small departmental team initiatives focused on improving effectiveness.
- All other duties as assigned.
- EDUCATION: Bachelor of Science or Bachelor of Arts in Science Field, Engineering Field or a related relevant discipline or equivalent work experience.
EXPERIENCE: Minimum of 2+ years experience within the pharmaceutical industry. Strong preference for previous quality / compliance experience, and previous complaint or adverse event experience.LEADERSHIP: Requires strong interpersonal, communication, collaboration, leadership skills; and ability to work in a diverse and flexible environment. Requires established ability to manage time with competing priorities. Requires ability to identify and implement continuous improvement principles. Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements. Ability to manage stakeholder feedback and persuade others to solve straightforward problems.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants 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.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range75 100,00 $ - 127 900,00 $
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.25%
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:1