Quality Assurance Associate II

Bridgewater, NJ

Posted: 09/04/2019 Industry: Biotech/R&D/Science Job Number: 49484

Duties:

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. 

Experience:

  • Minimum experience of 5 years in local or global Pharmacovigilance activities including case processing. 

Skills: 
  • 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) 

Education: 
  • 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)  should not have a certificate from Sollers. 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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