Job Title
Sr Quality Engineer
Requisition
JR000014727 Sr Quality Engineer (Open)
Location
St. Louis, MO
Additional Locations
Job Description Summary
The Senior 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, and 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:
- Write, review and approve Exceptions, OOSs, CAPAs, Customer Complaints and Change Controls in a computerized system
- Provide direct support for regulatory inspections and customer audits
- Ensure appropriate responses to internal, corporate, customer and regulatory audits/inspections
- Provide for and ensures appropriate support is provided for regulatory and customer inquiries
- 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
- Lead and participate in Root Cause Analysis and Process Improvement Teams
- Regularly use communication skills to exchange information, including technical, with other departments
- Follow all internal and basic cGMP guidelines for pharmaceutical operations
- Adhere to all safety rules and maintain 100% completion of all required training
MINIMUM REQUIREMENTS:
Education:
Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required; CQE Certification preferred
Experience:
- Minimum of 5 - 8 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment
- 2+ years of experience managing investigations, OOS, CAPAs and Change Controls
- Proven project management history
- Demonstrated expertise in root cause analysis tools
Preferred Skills/Qualifications:
- Excellent oral/written communication and leadership skills
- Ability to effectively communicate to customers, internal and external
- Understanding of basic statistical principles and regulatory expectations
- Proficient in Minitab, BPCS and TrackWise applications
- Knowledge of cGMP’s 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, Presentation Skills
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.
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.
Top Skills
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.
