job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Bridgewater Township, New Jersey
job type: Contract
salary: $23.81 - 28.01 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- The QA Associate is responsible for ensuring compliance with GVP, regulations and established procedures.
- They support the review of PV data (ICSRs, PSRs etc.) and utilize Quality Assurance databases and review documentation for compliance with GVP, FDA, ICH and other regulatory requirements and perform administrative tasks.
qualifications: Education & Qualifications
- Bachelor's degree in life sciences or related field required; certified health professional degree preferred but not required (example Pharmacist, Pharm D or Bachelor of nursing degree)
- Minimum experience of 5 years in local or global Pharmacovigilance activities including case processing.
- Understanding of Pharmacovigilance processes, PV database system, Dictionaries required
- Quality management experience required: (e.g. previous QA role, inspections and/or audits, experience with performing RCAs, corrective action plan (CAPA methodology) definition and implementation or Lean/ Six Sigma methodologies)
- Demonstrated knowledge of international regulations and guidelines like: International Conference on Harmonization (ICH), Council for International Organizations of Medical Sciences (CIOMS), European Medicines Agency (EMEA)/ Food and Drug Administration (FDA)
skills: FDA, Quality Assurance, Pharmacovigilance, CAPA, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.