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Customer Complaint Investigator

Pfizer


Location:
Kansas City, MO
Date:
12/01/2017
2017-12-012018-01-01
Pfizer
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Job Details

**ROLE SUMMARY**



The incumbent will conduct and document product complaint investigations. Investigations will be completed through the review of manufacturing records and associated deviations, examination of returned complaint samples, coordination of product reserve sample evaluation, and review of complaint histories and trends. The incumbent will track all product complaint investigations and assigned complaint categories. Where possible, the root cause of the complaint and corrective actions will be identified. Upon completion of these activities a final report will be prepared in accordance with established procedures.







**ROLE RESPONSIBILITIES**







+ Understand customer / patient use of and manufacturing processes for site manufactured, packaged and/or distributed products.



+ Track receipt, investigation and closure of product complaints to ensure adherence to established timelines.



+ Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template.



+ Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.



+ Submit Quality Notification Reports to site management for expedited complaints.



+ Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews.



+ Assure regulatory compliance of the complaint program is maintained. Perform periodic reviews of program-related SOPs / processes and revise as necessary. When required, perform / document a PQS Q1215 Product Complaints Compliance Analysis Status (CAS) assessment to assure alignment of site program SOPs / processes with PQS requirements; close identified gaps through SOP revision or other actions.



+ Support conduct of internal and external cGMP audits and regulatory agency inspections, and completion of post-audit / inspection commitments.



+ Support operations and quality management initiatives and objectives.







**QUALIFICATIONS**







+ Bachelor degree in Science or Engineering with 3 years of experience in the pharmaceutical / medical device industry working in a manufacturing environment.



+ Preferred incumbent will have 0 -1 years complaint investigation experience.



+ Knowledge and understanding of regulatory compliance / cGMP requirements for pharmaceutical / medical device manufacturing processes / operations



+ Demonstrated experience and skills in conduct and documentation of quality investigations related to pharmaceutical / medical device manufacturing processes



+ Excellent written and communication skills



+ Excellent organization skills with the ability / flexibility to react to changing deadlines and priorities



+ Demonstrated critical thinking and ability to pay close attention to detail and accuracy



+ Proficiency with Microsoft Word, Excel, Outlook, PowerPoint Required



+ Experience using Visio is a plus







**PHYSICAL/MENTAL REQUIREMENTS**



Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**







+ Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.



+ Must have the ability to work effectively under and manage to strict production, time and performance deadlines.



+ Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.



+ Travel between Brentwood and Westport locations required.







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.







This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.



**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







+ **Last Date to Apply for Job: 15 December, 2017**



+ **This job is (Pfizer) Exempt Role**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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