Job Title In-Process Quality Engineer IIRequisition JR000014574 In-Process Quality Engineer II (Open)Location St. Louis, MOAdditional Locations Job Description Summary The In-Process Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and oversight of the manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, with a focus on Customer Complaints. Serves as a technical leader in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.Job Description ESSENTIAL FUNCTIONS :
Manage and maintain Customer Complaints for the site
Write, review, and approve Exceptions, OOSs, CAPAs, Customer Complaints and Change Controls in a computerized system
Provide direct support for regulatory and customer inquiries/issues
Ensure appropriate responses to internal, corporate, customer and regulatory audits/inspections
Provide direct support for regulatory and customer inquiries/issues
Generate written correspondence and reports based on internal or customer requests in a timely manner
Lead and participate in Root Cause Analysis and Process Improvement Teams
Regularly use communication skills to exchange information, including technical, with other departments
Develop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issues
Report and present trends to management groups during scheduled review periods
Follow all internal and basic cGMP guidelines for pharmaceutical operations
Perform GMP walkthroughs with production on a routine basis
Adhere to all safety rules and maintain 100% completion of all safety required training
MINIMUM REQUIREMENTS :
Education:
Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required.Experience: Minimum of 3 - 5 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment
2+ years of experience managing investigations, OOS, CAPAs and Change Controls
Demonstrated expertise in root cause analysis tools
Preferred Skills/Qualifications:
Excellent oral/written communication and leadership skills
Understanding of basic statistical principles and regulatory expectations
Proficient in Metric Stream, BPCS and TrackWise applications
Knowledge of GMPs for APIs including ICH Q7, CFR 210 and 211
Knowledge of Quality Systems
Bias toward change, management of change, and achievement of results
Ability to quickly identify, communicate and/or resolve issues
Ability to build relationships with partners
Advanced Microsoft Office and computer skills
COMPETENCIES:
Decision Quality, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving, Drive for ResultsRELATIONSHIP WITH OTHERS: Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, 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.
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=)