What are the responsibilities and job description for the Product Complaint Analyst I position at Collins Consulting Inc?
Hybrid Role - Onsite 3 days / Remote 2 days
Candidates with Product Quality Complaint experience preferred and especially Device Complaint related experience.
Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal client customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding client product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities :
- Assure complaint records meet global requirements.
- Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
- Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
- Identification of potentially reportable events and notification to appropriate functional groups and management.
- Interface with Third Party Manufacturers, health care professionals, general public, internal customers, the client s functional areas and regulatory agencies.
Qualifications :
Additional Information From Manager :
What are the top 5 skills / requirements this person is required have?
Required Skill 1 : Detail oriented
Required Skill 2 : Microsoft Excel Knowledge and Experience Pivot tables, sorting, filtering are a must
Required Skill 3 : Adaptive to change
Required Skill 4 : Self-starter / independent worker
Required Skill 5 : Taking initiative to improve / create efficiency
What years of experience, education, and / or certification is required? 1 year quality and / or complaint handling experience. Degree.
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? 3-5 years quality and / or complaint handling experience. Degree in science, nursing, or equivalent.
This role requires sitting at a computer for 8 hours a day.
The benefits that you are eligible for with Collins Consulting, Inc :
