Job Information
Mallinckrodt Pharmaceuticals Sr Quality Systems Admin in St. Louis, Missouri
Job Title
Sr Quality Systems Admin
Requisition
JR000014429 Sr Quality Systems Admin (Open)
Location
St. Louis, MO
Additional Locations
Job Description Summary
The Sr. Quality Systems Admin provides support to LIMS, Chromeleon, LES, and other laboratory systems across multiple sites. Develops solutions to routine technical problems of moderate scope. Leads site projects and participates as a team member for corporate system projects. Reviews higher-level decisions for soundness of technical judgment and overall adequacy and accuracy with more senior team members or management. This position reports directly to the Sr. Quality Manager and works under limited supervision.
Job Description
ESSENTIAL FUNCTIONS:
Responsible for site system administration, user support, issue resolution and training related to the use of LV LIMS, Chromeleon CDS, BioVia LES, and other laboratory computer systems
Write, update, and obsolete procedures related to Chromeleon and laboratory chromatography data, LIMS, and LES
Creation of new product test procedures based on approved laboratory methods and SOPs
Installation and interface with new equipment
Design and implement maintainable configurations, extensions, and customizations
Develop and execute test scripts, create user manuals and other training material
Support ad-hoc and custom reporting
Participate as a team member delivering on approved projects
Ensure that all activities adhere to relevant policies, SOPs, and regulations
Work collaboratively across the organization, project team and with other groups as needed to ensure projects and support activities are executed successfully
Participate in periodic review and disaster recovery programs for computerized systems
Provide general technical support to IT departments as required
Part of a team that provides 24/7 on-call support
Adhere to all safety rules and maintain 100% completion of all safety required training
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
MINIMUM REQUIREMENTS:
Education:
BS or BA in Life Sciences, Engineering, Computer Science, related technical field or equivalent combination of education, experience, and competencies.
Experience:
A minimum of five years of relevant experience in the pharmaceutical or similarly regulated industry is required. Experience with laboratory computer systems required and preferably as an administrator, especially LabVantage LIMS, Chromeleon CDS, or BioVia LES.
Preferred Skills/Qualifications:
Self-motivated, demonstrates initiative.
Ability to write documents in a clear, concise manner.
Independence and sound decision making capabilities.
Excellent communication and customer service skills are required to provide clear instructions or information when working with clients, consultants, peers and others in the company.
Possess sufficient interpersonal skills to be able to function as part of a team.
Attention to detail and accuracy.
Experience programming with SQL, PL/SQL
COMPETENCIES:
Approachability, Customer Focus, Drive for Results, Negotiating, Written Communication, Integrity and Trust, Organizing, Priority Setting, Problem Solving, Technical Learning, Time Management
ORGANIZATIONAL RELATIONSHIP/SCOPE:
Reports to Sr. Quality Manager
Works under limited supervision.
Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.
Primarily internal company contacts with frequent inter-departmental contact on routine matters. Contacts include Information Technology, Quality Control, Quality Assurance, R&D, Corporate Quality and Regulatory, Manufacturing, and Logistics.
Contributes to the completion of milestones associated with specific projects and maintaining existing systems. Failure to achieve results or erroneous decisions or recommendations may cause delays in production or schedules and may impact Quality and Service.
WORKING CONDITIONS:
90% Office environment which includes sitting for long periods of time and computer use.
10% Laboratory and Plant environment exposure to temperature, noise, chemical or products.
Occasional Travel is required for projects, training and site support
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.
Additional information on Mallinckrodt’s hiring practices may be found by clicking