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In-Process Quality Eng II

Mallinckrodt Pharmaceuticals • Saint Louis, MO • 3w ago

Job Title

Requisition

JR000014911 In-Process Quality Eng II (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 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 require

At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.

Invest in your own career with Mallinckrodt and let's do something dynamic together.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

Additional information on Mallinckrodt's hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)

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