Business (Application) Administrator

LabAnswer; Foster City (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

LabAnswer is seeking an Application Administrator for the Quality Assurance department in Foster City, CA. This role involves managing application tasks for Trackwise, Documentum, and ComplianceWire, ensuring efficient application performance.

The ideal candidate has a strong background in QMS software administration, deep knowledge of pharmaceutical regulations, and excellent communication skills. A competitive compensation package based on experience and education is offered.

Qualifications

• Knowledge and experience with QMS software like Trackwise and Documentum.
• Understanding of pharmaceutical industry regulations, especially 21 CFR Part 11.
• Ability to perform detail-oriented work with high accuracy.

Responsibilities

• Perform daily business administrative tasks for application support.
• Analyze and deploy configurations to improve system efficiency.
• Train end users on necessary applications.
• Identify and resolve system issues, communicating effectively with stakeholders.

Skills

Administration of QMS software systems

Time management

Interpersonal communication

Analytical problem solving

Education

BA or BS

Job description

LabAnswer is the leading and largest laboratory informatics consultancy, combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.

Job Description

This individual will perform the role of Application Administrator in the Quality Assurance department for the Trackwise, Documentum, ComplianceWire applications.

• Performs daily business administrative tasks related to functional support of the applications.
• Analyzes, tests, and deploys configuration and reporting to improve the overall accuracy, efficiency, and effectiveness of the system.
• Effectively identifies and resolves system issues and appropriately communicates gating items to management and stakeholders.
• Trains end users on the applications as needed.
• Works on problems of greater complexity in scope where analysis of situations or data requires in-depth evaluation of various factors, and good judgment is required in resolving problems and making routine recommendations.
• Exercises judgment within well-defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Qualifications

• Knowledge and experience with the administration of QMS software systems (e.g. Trackwise, Documentum, ComplianceWire, etc.).
• Familiarity with database management system.
• Understanding of the current pharmaceutical industry and applicable regulations.
• Strong Knowledge of 21 CFR Part 11 and Annex 11 regulations.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Excellent verbal, written and interpersonal communication skills.
• Effective time management and interpersonal skills.
• Strong organizational skills, planning skills and must work effectively within teams.
• Demonstrates good coping skills and analytical problem solving skills.
• Must be able to provide solutions to moderately complex to semi-routine problems.
• Must have the ability to recognize deviation from accepted practice.
• Must be able to exercise judgment within generally well-defined procedures and practices to determine appropriate action.
• Typically requires a BA or BS and minimum 6 years of relevant progressive experience preferably in the pharmaceutical or biotech industry.

Competitive compensation package based on experience and education.