Pharmacovigilance QA Auditor Specialist
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine 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. Are you interested in joining a team delivering outstanding results to our customers and patients? Apply now for this exciting opportunity!
Requirements
- 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)
Nice To Haves
- Broad understanding of auditing process and landscape
- Audit experience in various audit types
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
