Overview
Process Quality Eng II Jobs in St. Louis, Missouri, USA at Mallinckrodt Pharmaceuticals
Position: In-Process Quality Eng II
Location: St. Louis
Job Title
In-Process Quality Eng II
Requisition
JR In-Process Quality Eng II (Open)
Location
St. Louis, MO
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 as a technical resource in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.
ESSENTIAL FUNCTIONS:
Review and approve Exception and OOS investigations, CAPAs, Change Controls, and Customer Complaints in Track Wise system
Generate data for Annual Product Reviews
Organize and document Material Review Boards for product disposition
Review release packets prior to final release of Finished Goods
Review and approve Validation Protocols
Participate in Root Cause Analysis and Process Improvement teams
Participate in Internal Audit Program
Support Regulatory filings and updates as applicable
Perform GMP walkthroughs with manufacturing on a routine basis
Provide direct support for regulatory inspections and customer audits
Follow all internal and basic cGMP guidelines for pharmaceutical operations
Adhere to all safety rules and maintain 100% completion of all safety required training
Maintain 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 environment
Experience with quality metrics, manufacturing investigations, and product release
Preferred Skills/
Qualifications:
Excellent verbal and written communication skills
Knowledge of cGMPs for APIs including ICH Q7, CFR 210 and 211
Knowledge of Quality Systems
Manufacturing or QC experience
Understanding of basic statistical principles and regulatory expectations
Ability to quickly identify, communicate and/or resolve issues
Ability to understand complex master processes
Ability to build and lead effective teams
Ability 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 required.
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Title: Process Quality Eng II
Company: Mallinckrodt Pharmaceuticals
Location: St. Louis, Missouri, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager)
