1+ months

Product Complaint Sr. Associate

Richmond, VA 23219

In compliance with current good manufacturing practices, the Sr. Product Complaint Associate is responsible for supporting the complaint handling Quality system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all Pfizer drug products, medical devices, software medical devices, and combination products with a device constituent within the scope of the Global Product Quality Complaints Group.


Essential Functions:

+ Triage all incoming reports in order to immediately identify the following:

+ Product, medical device, software medical device, and combination products with a device constituent complaints.

+ Complaints that require expedited processing due to potential compliance issues.

+ Responsible for recording and processing quality complaint information received into the global complaint database. This includes:

+ Entering new complaint records

+ Determine when a complaint should be investigated or recorded for trending purposes only.

+ Determine when a complaint sample should be retrieved for evaluation.

+ Issue response letters to complainants regarding product complaints received.

+ Contact reports either by email or phone, as necessary, to gather additional complaint information.

+ Complete daily workload while maintaining consistent, right first-time quality work and compliance with established procedures and timelines. This may require the Sr. Associate to triage and process a minimum number of reports on a daily basis as specified by the US Complaints Operations managers.


+ Understanding of Code of Federal Regulation (CFR) good manufacturing practices for finished pharmaceuticals with emphasis on complaint handling requirements.

+ Understanding/knowledge of drug product, medical device, packaging, and labeling with emphasis on complaint handling requirements.

+ BS with 0 years, Associates with 2 years relevant experience, or HS with 4 years relevant experience.


+ Experience with sterile and medical device product within a healthcare setting and/or manufacturing and packaging.

+ Experience with computer systems including database, spreadsheet and word processing applications.

+ Excellent oral and written communication skills that align with providing optimal levels of customer service, providing accurate product information, and compliance with good manufacturing practices and procedures.

+ Possess organizational skills/flexibility/teamwork in order to effectively prioritize daily workload and consistently maintain compliance with procedure timelines.

+ Must have ability to address obstacles with energy and determination and exhibit commitment to change and passion for Pfizer's best interests.


+ **Sitting and/or standing at a desk.**


+ **OTE**

+ **Monday - Friday**

+ **Normal business hours**

**Last Date to Apply for Job:** 11 May, 2020

**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.

**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 as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control


Posted: 2020-05-05 Expires: 2020-08-05

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Product Complaint Sr. Associate

Richmond, VA 23219

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