Job Title
In-Process Quality Engineer II
Requisition
JR000014574 In-Process Quality Engineer II (Open)
Location
St. Louis, MO
Additional 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 Results
RELATIONSHIP 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.
What We Do
At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission: Listening for needs and delivering solutions.
As a leader in specialty pharmaceuticals, we develop, manufacture, market and distribute innovative treatments for underserved patient populations within neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. . Our expertise also extends into acute and critical care hospital products, as well as our broad portfolio of generic prescription medicines and active pharmaceutical ingredients.
Together, we’re helping shape the future of the specialty pharmaceuticals industry by leveraging the values our founders instilled over 155 years ago – quality, integrity and service.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Equal Opportunity Employer
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.
