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Complaint Director Jobs (NOW HIRING)

Senior Complaint Specialist

Bedford, MA · On-site

$86K - $119K/yr

Minimum of 3+ years of direct experience in complaint handling and quality systems documentation. * Strong knowledge of FDA regulations including 21 CFR Part 820 and 21 CFR Part 211. * Working ...

Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions. * Reviews complaint codes and FDA Medical ...

Complaint Handling * Working through the Manager of Complaint Handling, direct the designated ... complaint handling unit, ensuring intake, triage, documentation, investigation, and closure satisfy ...

Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions. * Reviews complaint codes and FDA Medical ...

Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions. * Reviews complaint codes and FDA Medical ...

Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions. * Reviews complaint codes and FDA Medical ...

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Product Complaint Associate

Richmond, VA • On-site

Integrated Resources INC
Recruiting and Staffing Services • 51 - 200 employees

Contractor

Re-posted 27 days ago


Job description

Company Description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

This is Direct Hire with our Client

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


Integrated Resources logo

About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996