Job Title

In-Process Quality Engineer

Requisition

JR000015066 In-Process Quality Engineer (Open)

Location

St. Louis, MO

Additional Locations

Job Description Summary

The Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and support to 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 a technical resource in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.

Job Description

ESSENTIAL FUNCTIONS:

Review and approve Exception and OOS investigations, CAPAs, Change Controls, and Customer Complaints in TrackWise systemGenerate data for Annual Product ReviewsOrganize and document Material Review Boards for product dispositionReview release packets prior to final release of Finished GoodsReview and approve Validation ProtocolsParticipate in Root Cause Analysis and Process Improvement teamsParticipate in Internal Audit ProgramSupport Regulatory filings and updates as applicablePerform GMP walkthroughs with manufacturing on a routine basisProvide direct support for regulatory inspections and customer auditsFollow all internal and basic cGMP guidelines for pharmaceutical operationsAdhere to all safety rules and maintain 100% completion of all safety required trainingMaintain 100% on time Compliance Wire training

MINIMUM REQUIREMENTS:

Education:

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies

Experience:

Minimum 3-5 years of experience in Quality Assurance in a pharmaceutical manufacturing environmentExperience with quality metrics, manufacturing investigations and product release

Preferred Skills/Qualifications:

Excellent verbal and written communication skillsKnowledge of cGMPs for APIs including ICH Q7, CFR 210 and 211Knowledge of Quality SystemsManufacturing or QC experienceUnderstanding of basic statistical principles and regulatory expectationsAbility to quickly identify, communicate and/or resolve issuesAbility to understand complex master processesAbility to build and lead effective teamsAbility to build relationships with partners

COMPETENCIES:

Dealing with Ambiguity, Conflict Management, Decision Quality, Peer Relationship, Priority Setting, Customer Focus, Directing Others, Time Management, Drive for Results

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, Focus Factory Managers, 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 require