Job Function: Quality
Job Sub Function: Quality & Compliance Audit
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:We are searching for the best talent for Pharmacovigilance QA Auditor Specialist to be located at Raritan, NJ; Titusville, NJ or Horsham, PA. As a Pharmacovigilance Quality Assurance Auditor Specialist you will be part of a dynamic global team working to enhance quality across the Company through pharmacovigilance audit and business partner collaboration.
Key Responsibilities:- Leads the planning, conduct and reporting of routine PV internal and external audits
- Supports audits, data, internal facilities and processes in GxP/non-regulated areas
- Supports regulatory inspections in various supporting roles.
- Participates in projects or serves on teams, as assigned by supervisor.
- Provides consultation to business partners on routine tasks with occasional supervision.
- Collaborates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
- May assist in the preparation of training material if requested.
Qualifications Education:- Minimum Bachelor's degree is required; Focused degree in a life, natural, or computer science is preferred.
Experience and Skills:Required:- A minimum of 4 years of relevant work experience in Pharmacovigilance
- Strong project management experience
- Strong verbal and written skills, including presentation skills
- Strong teamwork and collaboration skills
- Strong in data analysis, critical thinking and attention to details
- Experience working with Microsoft Office tools (Outlook, Power Point, Excel, Word)
Preferred:- Broad understanding of auditing process and landscape
- Audit experience in various audit types
Other:- This position requires 25% of domestic and/or international travel
#LI-Hybrid
Required Skills:Preferred Skills:Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Audit Reporting, Business Behavior, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Detail-Oriented, Problem Solving, Quality Control (QC), Quality Standards, Regulatory Environment
The anticipated base pay range for this position is :$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
