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Complaint Analyst 1

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AbbVie

1mo ago

  • Job
    Full-time
    Entry & Junior Level
  • Healthcare
  • Austin

AI generated summary

  • You need knowledge of global regulatory requirements, FDA Quality Systems, and strong communication skills. A Bachelor’s degree or 1-2 years of relevant experience is required.
  • You will ensure complaint records comply with global standards, document and investigate non-medical complaints, interface with stakeholders, and provide quality customer service for complaint resolution.

Requirements

  • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
  • Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
  • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
  • Solid written/verbal communication and organizational skills.
  • Knowledge and application of computer systems for word processing and complaint management.
  • Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
  • A Bachelor's Degree required or 1-2 years of relevant work experience. Preferred degree in technology or scientific background (MLT, LPN, RN).
  • 0-2 years’ work experience in a cGMP related industry or in a clinical setting is preferred.

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 event.
  • 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, AbbVie functional areas and regulatory agencies.
  • Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.

FAQs

What is the role of a Complaint Analyst 1 at AbbVie?

The Complaint Analyst 1 processes pharmaceutical, medical device, and combination product complaints and inquiries, ensuring compliance with global regulatory requirements and Good Documentation Practices.

What qualifications are required for the Complaint Analyst 1 position?

A Bachelor's Degree is required, preferably in a technology or scientific background (MLT, LPN, RN), along with 0-2 years of relevant work experience in a cGMP related industry or clinical setting.

What skills are important for a Complaint Analyst 1?

Important skills include solid written and verbal communication, organizational abilities, good analytical skills, technical writing, and the ability to work effectively with cross-functional teams.

Is experience in a cGMP related industry required for this position?

While 0-2 years of experience in a cGMP related industry or clinical setting is preferred, it is not mandatory.

Will the Complaint Analyst 1 interact with external customers?

Yes, the role involves interfacing with external customers, including physicians, nurses, pharmacists, and the general public, as well as internal AbbVie departments and regulatory agencies.

What are some responsibilities of the Complaint Analyst 1?

Responsibilities include ensuring complaint records meet global requirements, documenting and investigating product complaints, identifying potentially reportable events, and coordinating quality customer service activities.

What regulatory knowledge is important for this position?

Knowledge of global regulatory requirements for pharmaceutical and medical devices, as well as FDA requirements for Quality Systems and Medical Device Reporting regulations, is preferred.

Is this position eligible for short-term incentive programs?

Yes, this job is eligible to participate in AbbVie’s short-term incentive programs.

What benefits does AbbVie offer to employees in this position?

AbbVie offers a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees.

Does AbbVie support diversity and inclusion in hiring?

Yes, AbbVie is committed to diversity and inclusion and employs qualified individuals without discrimination based on race, color, religion, national origin, age, sex, disability, or other legally protected statuses.

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AbbVie

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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