Job Description

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.
Conduct investigation into potential trend signals, including review of risk management file and coordination of cross-functional investigation team meetings as required per SOP.
Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.
Initiate and submit Quality Notification To Management records as required per procedure, including when new risks are identified during the course of the investigation.
Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews.
Perform periodic reviews of program-related SOPs / processes and revise as necessary.
Perform gap assessments to assure alignment of site program SOPs with policy; close identified gaps through SOP revision or other actions.
Support internal and external cGMP audits and regulatory agency inspections, and completion of post-audit / inspection commitments.
Support additional projects and initiatives as directed by management.

BASIC QUALIFICATIONS
Bachelor degree in Science or Engineering
3 years of experience in the pharmaceutical / medical device industry working in a manufacturing environment.
Preferred incumbent will have 1+ years complaint investigation experience.
Knowledge and understanding of regulatory compliance / cGMP requirements for pharmaceutical / medical device manufacturing processes / operations
Demonstrated technical writing ability, preferably including experience with conduct and documentation of quality investigations
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

PHYSICAL/MENTAL REQUIREMENTS

Activities might include Lifting complaint samples and documents, sitting, standing, walking, bending, ability to perform detail oriented work and data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work on site at the WestPort location and from a home office environment. Ability to work overtime as needed.

The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (green card holders), Refugees and Asylees.

Last Date to Apply for Job: March 9, 2021

Eligible for Employee Referral Program

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 providers 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