QA NCR and Complaint Investigator (Pharmaceutical Manufacturing) at Jobot

Philadelphia, PA 19115

About the Job

QA NCR and Complaint Investigator - 2+ years of experience!

This Jobot Job is hosted by: Jake Benyshek
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $65,000 - $75,000 per year

A bit about us:

We are a family-owned contract manufacturer based in Philadelphia, PA, with over 90 years of experience. Our expertise lies in manufacturing pharmaceutical, nutritional, and cosmetic products for both human and veterinary use. We prioritize our employees and clients, ensuring exceptional experiences and attracting a diverse range of customers, from start-ups to Fortune 20 companies worldwide. Choose us for quality, reliability, and innovation.

If you have Quality Assurance experience within Pharmaceutical Manufacturing industry that aligns with the description below, then please apply!

Why join us?

Do you want to work with a company who are helping people around the world? We do too!

Meaningful Work!
Competitive Compensation Package!
Complete Benefits Package!
Accelerated Career Growth!
Fun Company Activities!
Many More!

Job Details

REQUIREMENTS:

Bachelor's Degree
2+ years of experience in the pharmaceutical industry or medical device manufacturing
Must have experience in Quality Documentation Management
Experience creating and reviewing non-conforming material reports
Technical writing experience - must have experience from initiation to closure with NCRs and CAPAs

RESPONSIBILITIES:

Collaborate with cross-functional teams to accurately initiate, investigate, document, review, and approve non-conformances and deviations.
Ensure timely and proper closure of Non-Conformance Reports (NCRs) by following up with relevant departments.
Track and analyze Non-Conformance and other Quality Metrics for trend identification.
Maintain and update the NCR Log and associated files.
Actively participate in quality process improvement projects and initiatives.
Conduct thorough investigations into non-conforming events in manufacturing and packaging, including the review of cGMP documents and historical data within the quality management system.
Collaborate with team members to determine the true root cause of events and participate in defining appropriate Corrective and Preventive Actions (CAPA).
Conduct personnel interviews related to the events under investigation.

]- Draft concise and accurate event investigation reports with the aim of achieving successful first-pass quality reviews.
Do you- Investigate customer complaints to identify root causes and recommend appropriate CAPA.

Collaborate with Process Owners to ensure compliance with the complaint handling process.
Coordinate with Operations to determine whether reported complaints are associated with manufacturing or packaging issues and assess the completeness and accuracy of complaint documentation.
Escalate new or unknown risks or hazards for further evaluation and decision-making.
Work with multidisciplinary and cross-functional teams to ensure the timely completion and closure of complaints.
Perform any additional duties as required by the Manager.

Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.