Product Complaint Associate

Job Description

Position Summary: 

In compliance with current good manufacturing practices, the Product Complaint Associate is responsible for supporting the timely processing, distribution, customer service and administrative duties for quality defect allegations reported for all human drug products within the scope of the Product Quality Complaints (PQC) Group.

Essential Functions: 

• Triaging all received complaints in order to immediately identify any potentially expedited quality/compliance issues. 

• Responsible for recording any quality complaint information received into the PQC complaint database. 

• This includes entering new complaints; determine when a complaint should be investigated or recorded for trending purposes only, and when a complaint sample should be retrieved for evaluation. Issue response letters to complainants regarding product complaints received. Responsible for bringing any potential product trend to PQC management attention. 

• Maintain consistent quality work and compliance in addition to completing the daily workload. 

• Ability to make quality decisions based on policies and procedures. Ability to appropriately manage confidential information.

Other Duties: 

Participate in training on-site colleagues regarding complaint handling. Participate in GMP training at least once a year.

Principal Relationships: 

Internal Contacts – 

• Constant communication with Quality Assurance Product Complaint colleagues as well as other individuals within the organization. 

• Frequent interaction and communication with internal colleagues at domestic and international locations. 

• Daily contact with colleagues from Drug Safety, Medical Information, Corporate Legal, Marketing. External Contacts.

Qualifications

Qualification-

• Bachelor’s or Associate Degree or High School graduate with equivalent experience.

• Bachelors or Associate degree with a minimum of 1-3 years’ experience in a related field, or a high school graduate with a minimum of 3-5 years in a related field. 

• Understanding of Code of Federal Regulation good manufacturing practices for finished pharmaceuticals with emphasis on complaint handling requirements. 

• Experience with personal computing systems including database, spreadsheet and word processing applications. 

• Excellent oral and written communication skills and organizational skills.

• 1-3 years of Pharma experience

• 1-3 years of experience in Quality Assurance

Additional Information

This is Direct Hire with Our Client