Job Title

Sr Quality Engineer

Requisition

JR000014727 Sr Quality Engineer (Open)

Location

St. Louis, MO

Additional Locations

Job Description Summary

The Senior 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, and 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:

Write, review and approve Exceptions, OOSs, CAPAs, Customer Complaints and Change Controls in a computerized systemProvide direct support for regulatory inspections and customer auditsEnsure appropriate responses to internal, corporate, customer and regulatory audits/inspectionsProvide for and ensures appropriate support is provided for regulatory and customer inquiriesDevelop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issuesReport and present trends to management groups during scheduled review periodsLead and participate in Root Cause Analysis and Process Improvement TeamsRegularly use communication skills to exchange information, including technical, with other departmentsFollow all internal and basic cGMP guidelines for pharmaceutical operationsAdhere to all safety rules and maintain 100% completion of all required training    

MINIMUM REQUIREMENTS:

Education:

Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required; CQE Certification preferred

Experience:

Minimum of 5 - 8 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment 2+ years of experience managing investigations, OOS, CAPAs and Change ControlsProven project management historyDemonstrated expertise in root cause analysis tools

Preferred Skills/Qualifications:

Excellent oral/written communication and leadership skillsAbility to effectively communicate to customers, internal and externalUnderstanding of basic statistical principles and regulatory expectations Proficient in Minitab, BPCS and TrackWise applicationsKnowledge of cGMP’s for APIs including ICH Q7, CFR 210 and 211Knowledge of Quality SystemsBias toward change, management of change, and achievement of resultsAbility 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, Presentation Skills

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. 

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.