MALLINCKRODT ENTERPRISES, LLC Quality Engineer in Webster Groves, Missouri
JOB DESCRIPTION SUMMARY OF POSITION: The Quality Engineer II performs a variety of quality-related functions with the intent of providing Quality support to manufacturing operations at the Webster Groves 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 deficiencies * Identify exceptions and report exceptions * Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release * Execute line clearances * Perform batch record accountability * Create and/or revise Quality related SOPs * Review and approve exceptions, change controls and CAPAs in the Quality Stream module. * Review of data for release APIs, Excipients, and Finished Bulk Product. * Perform supplier qualification activities including desk audits and supplier approvals * Review validation documentation including equipment qualification and process validation * Participate in Root Cause Analysis teams. * 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 compliance wire training MINIMUM REQUIREMENTS: Education: BS in Chemistry, Biology, related science or equivalent combination of education, experience, and competencies. Experience: * Minimum of 3-5 years' experience in Quality Assurance in a pharmaceutical manufacturing environment. Preferred Skills/Qualifications: * Excellent communication and leadership skills. * Knowledge of GMP's for Dosage Products. * Understanding of basic statistical principles, knowledge of validation principles, techniques, and regulatory expectations. * Knowledge of Quality Systems. * Ability to quickly identify, communicate and/or resolve issues. * Ability to build relationships with partners. * Good verbal and written communication skills. Skills/Competencies: Dealing with Ambiguity, Conflict Management, Decision Quality, Peer Relationship, Priority Setting, Customer Focus, Directing Others RELATIONSHIP WITH OTHERS: Daily interaction with Manufacturing personnel, Quality Engineers, RandD 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 compounds. 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..Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Employer's Job# JR000008662Please visit job URL for more information about this opening and to view EOE statement.