• In-Process Quality Eng II

    Mallinckrodt Pharmaceuticals (St. Louis, MO)


    Job Title

     

    In-Process Quality Eng II

     

    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=)