In-Process Quality Engineer II

Job Title

In-Process Quality Engineer II

Requisition

JR000014574 In-Process Quality Engineer II (Open)

Location

St. Louis, MO

Additional Locations

Job Description Summary

The In-Process Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and oversight of the manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, with a focus on Customer Complaints. Serves as a technical leader in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.

Job Description

ESSENTIAL FUNCTIONS:

• Manage and maintain Customer Complaints for the site
• Write, review, and approve Exceptions, OOSs, CAPAs, Customer Complaints and Change Controls in a computerized system
• Provide direct support for regulatory and customer inquiries/issues
• Ensure appropriate responses to internal, corporate, customer and regulatory audits/inspections
• Provide direct support for regulatory and customer inquiries/issues
• Generate written correspondence and reports based on internal or customer requests in a timely manner
• Lead and participate in Root Cause Analysis and Process Improvement Teams
• Regularly use communication skills to exchange information, including technical, with other departments
• Develop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issues
• Report and present trends to management groups during scheduled review periods
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Perform GMP walkthroughs with production on a routine basis
• Adhere to all safety rules and maintain 100% completion of all safety required training

MINIMUM REQUIREMENTS:

Education:

Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required.

Experience:

Minimum of 3 - 5 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment 

• 2+ years of experience managing investigations, OOS, CAPAs and Change Controls
• Demonstrated expertise in root cause analysis tools

Preferred Skills/Qualifications:

• Excellent oral/written communication and leadership skills
• Understanding of basic statistical principles and regulatory expectations 
• Proficient in Metric Stream, BPCS and TrackWise applications
• Knowledge of GMPs for APIs including ICH Q7, CFR 210 and 211
• Knowledge of Quality Systems
• Bias toward change, management of change, and achievement of results
• Ability to quickly identify, communicate and/or resolve issues 
• Ability to build relationships with partners 
• Advanced Microsoft Office and computer skills

COMPETENCIES:

Decision Quality, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving, Drive for Results

RELATIONSHIP WITH OTHERS:

Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, and Quality Management members to provide guidance to resolve issues.

WORKING CONDITIONS:

• 10% Laboratory exposure to plant products, solvents, reagents, some of which are hazardous or potent compounds.
• 10% Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
• 80% Office environment which requires sitting for long periods of time and computer use.