ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified QC E-systems Sr. Business Analyst.
The QC E-systems Business Analyst will be responsible for the development, deployment and administration/maintenance of the Argos Quality Control Laboratory Information Systems. The Analyst creates and maintains procedures (SOPs), configures and customizes the systems and provides support and training to all end users.
The ideal candidate will possess a strong work ethic, the desire to work on a collaborative team, and a passion for creative thinking and problem solving.
- Responsible for the deployment of LIMS. This includes creation and technical review of validation documentation (URS, FDS, SDS, IQ/OQ/PQ test scripts).
- Provides daily technical support to LIMS users in support of QC laboratory operations.
- This includes database administration, design, management and maintenance.
- Represents department on project and cross functional teams / committees.
- Trains Subject Matter Experts on new or modified LIMS configuration.
- Responsible for technical lead role to support QC equipment software and firmware validations (e.g. flow cytometers, gel imagers, spectrophotometers, non-viable particulate counters)
- Evaluates product enhancements and capabilities; creates and follows through with LIMS related Change Controls.
- Performs other duties as required. These will include participation in ERP implementation and other systems required for commercial operations.
- Bachelorâ€™s degree in a scientific discipline (chemistry, biochemistry, or chemical engineering) or Computer Science
- Experience with deployment of LIMS and 5+ years of LIMS administration in the biotech/pharmaceutical/medical device industry.
- Knowledge of FDA cGMP and related regulations and guidelines including 21 CFR part 11.
- Specific knowledge of computer validation methodologies, principles and software development life cycles.
- Sample Life Cycle
- Templates (Batch, Sample, Lot, Stability protocols)
- Manager (Batch manager, Stability study manager, Lot Manager, Instrument manager)
- Rule and Event manager, User Management
- Analysis and Production specification builds
- Interfaces (Instrument interface)
- Experience with LabWare LIMS and instrument integration using LabStation preferred.
- Experience with Lonza MODA (EM) preferred.
- Good communication and interpersonal skills required.
- Must have initiative, high attention to detail, and the ability to multi-task.
- Ability and willingness to be regularly, predictably and reliably at work.
The candidate should have experience in the following LIMS areas:
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.