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Become A Complaint Investigations Officer

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Working As A Complaint Investigations Officer

  • Evaluating Information to Determine Compliance with Standards
  • Identifying Objects, Actions, and Events
  • Communicating with Supervisors, Peers, or Subordinates
  • Resolving Conflicts and Negotiating with Others
  • Analyzing Data or Information
  • Mostly Sitting

  • Make Decisions

  • $89,314

    Average Salary

What Does A Complaint Investigations Officer Do At Pfizer

* Conduct complaint investigations for defects reported against product released from the site.
* Facilitate cross functional partnerships within Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other plant personnel to complete the investigation.
* Conduct personnel interviews and system reviews.
* Act as an unbiased investigator with questions surrounding the specific issue.
* Evaluate corrective actions in regards to trends.
* Identify and implement preventive actions to eliminate the potential for non-conformities to occur.
* Perform follow-up activities to coordinate the completion of corrective and/or preventive actions.
* Perform effectiveness checks for investigations.
* Remain current in regulatory expectations and industry practices regarding investigations and CAPA

What Does A Complaint Investigations Officer Do At Agilent Technologies, Inc.

* EU, FDA and ROW Complaint Investigation compliance, health hazard evaluation, medical device reporting, and post market surveillance of human, oncology and prenatal next generation sequencing products.
* Complaint investigation of assays involves microarrays, reagents, instruments, and software.
* Evaluate all incoming complaints (internal or external) to determine the level of investigation required and any reporting to regulated bodies and field.
* Trend and evaluate systemic issues and perform root cause analysis, corrective actions and preventive action (CAPA) for complaints, as necessary.
* Perform health hazard evaluation and risk assessment and determine and document for any recalls, field corrections and medical device reporting.
* Develop effective testing parameters to understand the root cause of the complaint using input from the customer and internal SOPs.
* Maintain customer complaint documentation including complaint details, product return information as per the regulatory requirements.
* Communicate with marketing, R&D; and operations personnel during the course of the investigation of customer complaints
* Manage interdepartmental/global teams to investigate and correct the root cause of all verified complaints through the established CAPA system.
* Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required.
* Communicate findings to technical services and management in concise summary formats.
* Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies.
* These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc.
* Monitor MedWatch for any unreported claims and evaluate the need for an investigation.
* Track, compile, and report on complaint metrics.
* Qualifications
* Bachelors or Master’s degree in Biological Sciences or equivalent (BioInformatics, Chemistry or Bio
* Chemistry is a plus)
* to 5 years of laboratory bench work experience
* This is an advanced level hire.
* Up to 5% travel may be required.
* Familiarity with ISO 13485, ISO 17025 and QSR quality management system requirements and IVD products.
* Proficient in Microarray testing, biological reagent testing, data analysis and workflow troubleshooting including instrumentation,
* arrays and biological materials.
* Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer.
* We value diversity at all levels.
* All individuals, regardless of personal characteristics, are encouraged to apply.
* All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
* For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here:
* https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,
* https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
* Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities.
* If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact
* US and Canada only) or email job_posting@agilent.com.
* EOE AA M/F/Vet/Disability
* Date Posted:
* Jan/18
* Requisition:
* Job Title:
* Regulated Products Complaint Investigator
* Business:
* Diagnostics and Genomics Group
* Job Category:
* Quality/Regulatory
* Job Sub
* Category:
* Quality
* Region:
* Americas
* Country or Area:
* United States
* State/Province:
* California
* Town/City:
* Santa Clara
* Shift:
* Day Job
* Job Type

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Complaint Investigations Officer Demographics

Gender

Female

54.5%

Male

44.4%

Unknown

1.0%
Ethnicity

White

75.2%

Hispanic or Latino

14.4%

Asian

9.5%

Unknown

0.5%

Black or African American

0.4%
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Languages Spoken

Spanish

85.7%

Carrier

14.3%

Complaint Investigations Officer Education

Schools

Northeastern University

12.1%

New York University

9.1%

University of Phoenix

9.1%

Liberty University

6.1%

Vermont Law School

6.1%

Bentley University

6.1%

Southern New Hampshire University

6.1%

Community College of Allegheny County

6.1%

San Jose State University

6.1%

University of Arkansas for Medical Sciences

3.0%

Syracuse University

3.0%

University of Northern Colorado

3.0%

University of North Carolina at Greensboro

3.0%

Allen University

3.0%

Tusculum College

3.0%

Union County College

3.0%

University of Washington

3.0%

Harvard University

3.0%

University of Arkansas, Fayetteville

3.0%

University of Alabama

3.0%
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Majors

Business

14.3%

Nursing

12.5%

Law

7.1%

Social Work

7.1%

Chemistry

7.1%

Criminal Justice

7.1%

English

5.4%

Theology

3.6%

Medical Technician

3.6%

Pharmacy

3.6%

Biology

3.6%

Mechanical Engineering

3.6%

Elementary Education

3.6%

Clinical Psychology

3.6%

Biomedical Engineering

3.6%

Engineering And Industrial Management

3.6%

Management

1.8%

Manufacturing Engineering

1.8%

Culinary Arts

1.8%

Political Science

1.8%
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Degrees

Bachelors

38.6%

Masters

21.7%

Other

16.9%

Associate

8.4%

Doctorate

8.4%

Certificate

4.8%

Diploma

1.2%
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Part Time
Internship
Temporary

Top Skills for A Complaint Investigations Officer

CustomerComplaintsRegulatoryComplianceRegulatoryAgenciesComplaintInvestigationServicesFDACorrective/PreventiveActionConsumerComplaintsEEOCapaComplaintProcessTrackwiseAdditionalActionPlansLaboratorySettingCustomerServiceCivilRightsTransgressorsInvestigationFindingsBrainDisorderComplaintDataLegalResearch

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Top Complaint Investigations Officer Skills

  1. Customer Complaints
  2. Regulatory Compliance
  3. Regulatory Agencies
You can check out examples of real life uses of top skills on resumes here:
  • Received return product due to customer complaints and able to document clearly and accurately into IQ program.
  • Assured timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for Medical Devices.
  • Investigate reported incidents and consumer complaints.
  • Applied clear understanding of EEO rights, Title VII, section 1983 to postal workers.
  • Used deviation management, CAPA, trending, metrics and cross functional teams to improve product quality.

Top Complaint Investigations Officer Employers

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