Global Product Surveillance Quality Associate II

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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