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.
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.
