Global Product Surveillance Quality Associate II

Overview

Hybrid
$25 - $26
Contract - W2
Contract - 12 Month(s)

Skills

Responsible for complaint handling
Bachelors degree required
2-5 years relevant work experience in cGMP related industry or in a clinical setting.

Job Details

Immediate need for a talented Global Product Surveillance Quality Associate II. This is a 12+months contract opportunity with long-term potential and is located in Medina, NY (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-71054

Pay Range: $25 - $26/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan .

Key Responsibilities:

  • This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
  • The incumbent will perform other duties assigned.
  • Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
  • Collect necessary complaint information for investigations.
  • Determine reportability of a complaint.
  • Respond to customer complaints (written or verbal) and write technical investigation response letters.
  • Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams).
  • May lead projects as assigned by management.
  • May have technical approver responsibilities.
  • Manage workflow; identify and escalate issues.
  • Participate in mentoring and training of the Product Surveillance team.
  • Ability to perform all duties required of previous levels.
  • Will need strong writing:
  • This section focuses on the main purpose of the job in one to four sentences.
  • This position is responsible for complaint handling, will triage incoming complaints for the assigned team, and will process all levels of complaints without supervision.

Key Requirements and Technology Experience:

  • Key Skills: Responsible for complaint handling
  • Bachelor s degree required
  • 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
  • Understanding of the products intended use and manufacturing process of assigned products.
  • Strong technical writing skills, able to review complaint investigations and write customer response letters.
  • Readily accepting of assignments to new/ different products.
  • Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
  • Excellent written/verbal communication and organizational skills.
  • Ability to make independent decisions with minimum oversight.
  • Strong problem solving and analytical skills.
  • Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.
  • Include the education and experience that is necessary to perform the job satisfactorily.
  • Bachelor degree required.
  • 2-5 years relevant work experience in cGMP related industry or in a clinical setting.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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