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.
LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.
The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.
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.
• Analyses, tests, and deploys configuration, 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, 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 is required.
• 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.
Additional InformationAt LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for excellent people to join our team, those who are looking to join a company for
the long term. Our consultants are team players and are the best at what they do. Please read our employee value proposition and philosophy statement at www.labanswer.com to see if you are the right match for LabAnswer
Skills Required
- Bachelor’s degree, typically a BA or BS
- Minimum six years of relevant progressive experience
- Experience administering QMS software systems such as TrackWise, Documentum, or ComplianceWire
- Familiarity with database management systems
- Understanding of the pharmaceutical industry and applicable regulations
- Strong knowledge of 21 CFR Part 11 and Annex 11 regulations
- Detail-oriented work with a high degree of accuracy
- Excellent verbal, written, and interpersonal communication skills
- Effective time management and interpersonal skills
- Strong organizational and planning skills; ability to work effectively within teams
- Analytical problem-solving and coping skills
- Ability to provide solutions to moderately complex or semi-routine problems
- Ability to recognize deviations from accepted practice
- Ability to exercise judgment within defined procedures and practices
- Pharmaceutical or biotech industry experience
What We Do
LabAnswer is a laboratory informatics consultancy that combines scientific, laboratory, regulatory and information-technology expertise. It designs, architects, implements, deploys and supports scientific data-management and laboratory-automation systems. The company has delivered solutions across pharmaceuticals, biopharmaceuticals, medical devices, forensics and life-sciences research, serving research, development and manufacturing/QC laboratories and helping organizations manage scientific data and improve laboratory operations through integrated informatics and automation projects.
