Quality Engineer chez PharmaLink, LLC

Description

The Quality Engineer works directly with both QA and QC to support and enhance quality systems within our pharmaceutical reverse distribution operations.? The Quality Engineer will oversee the improvement of quality processes for efficiency, and effectiveness and establish KPIs to meet customer demand. The Quality Engineer will both lead or participate in internal/external investigations, the development of CAPAs, and will lead process improvement projects for the organization.? The Quality Engineer will extract data from SQL, conduct advanced data analysis to support continuous improvement for our facility and create various reports to deliver quality metrics across the site using tools such as Power BI.?This is an exempt position that reports to the Director of Quality & Regulatory Affairs.? 

KEY RESPONSIBILITIES:

• Support the development, implementation, and continuous improvement of the Quality Management System (QMS) in compliance with regulatory and company requirements.  
• Monitor and analyze operational data related to reverse distribution of pharmaceuticals to identify trends, deviations, and opportunities for improvement.? 
• Complete understanding of all processes throughout the Operations Department including but not limited to: Receiving, Returns Storage (FIFO), Processing, Sorting and Packing.? 
• Utilize SQL to query operational databases and extract data needed for compliance and performance reporting.? 
• Develop, maintain, and present dashboards and reports using Power BI to support quality metrics, KPIs, and decision-making processes.? 
• Investigate deviations, customer complaints, CAPAs, and audit findings using root cause analysis and risk-based approaches.? 
• Investigate and correct discrepancies in multiple reports from IT/Acct/ETC.? 
• Collaborate with IT, operations, compliance, and warehouse staff to ensure quality-related data is accurate, complete, and readily available.? 
• Participate in internal and external audits, ensuring preparedness and maintaining accurate quality records.? 
• Contribute to the training of staff in GMP, GDP, and quality procedures as applicable.? 
• Engage stakeholders cross functionally ensuring alignment and support for projects.?? 
• Facilitate process improvement activities and be accountable for driving project and achieving results.? 
• Engage with operations staff to determine process improvement needs.? 
• May perform additional duties as required.? 

Requirements

QUALIFICATIONS:

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.? 

3+ years of experience in a quality assurance, quality engineering, or compliance role in a regulated industry.? 

Proficiently in SQL for querying databases and generating custom reports.? 

Experience with Power BI or similar data visualization tools for real-time reporting and analysis.? 

Demonstrated skill in advanced data analysis, root cause analysis, and statistical process control.? 

Familiarity with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and 21 CFR Part 11.? 

Excellent written and verbal communication skills with attention to detail.? 

Strong problem-solving abilities and a proactive, collaborative mindset.? 

PREFERRED QUALIFICATIONS:

Experience working in a DEA-licensed facility or reverse logistics environment.? 

Knowledge of quality risk management principles (ICH Q9).? 

Experience with QMS software and electronic documentation systems.? 

Proficient with Microsoft Office 365 and Visio.? 

Six Sigma Green or Black Belt certification.? 

PHYSICAL REQUIREMENTS:

Prolonged periods sitting at a desk and working on a computer.? 

RELATIONSHIPS:

In performing the above responsibilities, the Quality Engineer maintains the following relationships:  

• The incumbent is accountable to the Director of Quality & Regulatory Affairs fulfilling the above responsibilities and others, which may be assigned. 
• As a service organization with a commitment to quality, it is the responsibility of each employee to maintain accurate and professional demeanor with colleagues and customers. 

PharmaLink reserves the right to revise or change job duties and responsibilities as the need arises. 

Note: Please submit your request in writing to Human Resources if you wish to discuss reasonable accommodations to help you perform the essential functions of this job.?