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Job Description
ROLE SUMMARY
In compliance with current good manufacturing practices, the 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 within the scope of the Global Product Quality Complaints (GPQC) Group.
ROLE RESPONSIBILITIES
Essential Functions:
- Triage all received complaints in order to immediately identify any potentially expedited quality/compliance issues.
- Responsible for recording quality complaint information received into the global complaint database. This includes:
- Entering new complaints
- Determine when a complaint should be investigated or recorded for trending purposes only
- When a complaint sample should be retrieved for evaluation.
- Issue response letters to complainants regarding product complaints received.
- Complete daily workload while maintaining consistent, quality work and compliance with established procedure and timelines. This may require triage or action on a minimum number of complaints daily as specified by determined by the US Complaints Operations managers.
- Contact reporter, as necessary, to gather additional complaint information to ensure the site may adequately evaluate the alleged complaint.
- Complete required training within designated time frames and participate in annual GMP training
Other Duties as assigned:
- Triage, distribute, and/or act on information received in departmental mailbox (e.g., PCG Central)
- Maintain required logs
- Maintain departmental documentation including, but not limited to job aids, guidance, local checklists, etc.
- Maintain departmental voicemail box which includes but is not limited to performing call backs to reporters and updating the applicable complaint record.
- Participate in, when applicable, departmental projects
QUALIFICATIONS
Bachelors or Associate degree with a minimum of 1-3 years experience in a related field, orHigh School Diploma with a minimum of 3-5 years in a related field.
Additional Qualifications:
- Understanding of Code of Federal Regulation (CFR) good manufacturing practices for finished pharmaceuticals with emphasis on complaint handling requirements.
- Experience with computer systems including database, spreadsheet and word processing applications.
- Excellent oral and written communication skills
- Organizational skills
- Must be flexible with regard to changing and conflicting priorities, able to easily shift gears in response to ambiguity and the needs of the situation
- Must have ability to address obstacles with energy and determination and exhibit commitment to change and passion for Pfizer's best interests
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
During regulatory authority inspections, overtime may be required.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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