Job Information
Mallinckrodt Pharmaceuticals Sr In-Process Quality Eng in Fenton, Missouri
Job Title
Sr In-Process Quality Eng
Requisition
JR000014450 Sr In-Process Quality Eng (Open)
Location
Fenton, MO
Additional Locations
St. Louis, MO
Job Description Summary
Job Description
SUMMARY OF POSITION:
The Senior Quality Engineer performs a variety of quality-related functions with the intent of providing Quality support to manufacturing operations at the Fenton Manufacturing Plant. This will include new manufacturing processes that are transferred to the site. The scope of the position includes manufacturing batch record review, manufacturing and quality investigations, CAPA’s, change controls, supplier quality and validation.
ESSENTIAL FUNCTIONS:
Execute batch record review and document deficienciesIdentify exceptions and report exceptionsResolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material releaseExecute line clearancesPerform batch record accountabilityCreate and/or revise Quality related SOPsReview and approve exceptions, change controls and CAPAs in the Trackwise module.Review of data for release APIs, Excipients, and Finished Bulk ProductPerform supplier qualification activities including desk audits and supplier approvalsAuthor and/or review validation documentation including equipment qualification and process validationParticipate in, or Lead Root Cause Analysis teamsFollow all internal and basic cGMP guidelines for pharmaceutical operationsAdhere to all safety rules and maintain 100% completion of all safety required trainingMaintain Compliance Wire training
MINIMUM REQUIREMENTS:
Education:
BS in Chemistry, Biology, related science or equivalent combination of education, experience, and competencies
Experience:
Minimum of 5-7 years' experience in Quality Assurance in a pharmaceutical manufacturing environment
Preferred Skills/Qualifications:
Excellent communication and leadership skillsKnowledge of GMP's for Dosage ProductsKnowledge of Supplier Quality or Validation PrinciplesUnderstanding of basic statistical principles, and regulatory expectationsKnowledge of Quality SystemsAbility to quickly identify, communicate and/or resolve issuesAbility to build relationships with partnersGood verbal and written communication skills
COMPETENCIES:
Dealing with ambiguity, approachability, decision quality, functional/technical skills, integrity and trust. Customer Focus, managing diversity, fairness, managing and measuring work, motivating others.
RELATIONSHIPS WITH OTHERS:
Reports directly to the Plant Quality Manager. Daily interaction with Manufacturing personnel, Focus Factory Managers, and Quality Management members to provide guidance to resolve issues.
WORKING CONDITIONS:
20% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds80% office environment which includes 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.
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.
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