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 systemsWrite, update, and obsolete procedures related to Chromeleon and laboratory chromatography data, LIMS, and LESCreation of new product test procedures based on approved laboratory methods and SOPsInstallation and interface with new equipmentDesign and implement maintainable configurations, extensions, and customizationsDevelop and execute test scripts, create user manuals and other training materialSupport ad-hoc and custom reportingParticipate as a team member delivering on approved projectsEnsure that all activities adhere to relevant policies, SOPs, and regulationsWork collaboratively across the organization, project team and with other groups as needed to ensure projects and support activities are executed successfullyParticipate in periodic review and disaster recovery programs for computerized systemsProvide general technical support to IT departments as requiredPart of a team that provides 24/7 on-call supportAdhere 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 ManagerWorks 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.