Job Title

Complaint Investigator; Senior Complaint Investigator

Job Description

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
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.

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
EDUCATION AND EXPERIENCE
• Bachelor degree in Science or Engineering with 8 years of experience in the pharmaceutical / medical device industry working with investigation processes in a manufacturing environment.
• Preferred incumbent will have 4 years complaint investigation experience.

TECHNICAL SKILLS REQUIREMENTS
• 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
• Commitment to quality and customer service
• 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
• Aptitude for and demonstrated use of computerized systems to run queries and reports
• Self-motivated and able to work independently and in a team environment

Equal Employment Opportunity
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.


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Desired Skills and Expertise

Bachelor's Degree

Industry

Pharmaceutical

Experience

5+ years

Job Type

Full Time

Salary / package

Not Specified