Job Openings Clinical Computer Systems Validation Technical Writer / QA Tester, Remote
About the job Clinical Computer Systems Validation Technical Writer / QA Tester, Remote
Clinical Computer Systems Validation Technical Writer / QA Tester, Remote
- Long-term Contract or Direct Hire
- Remote (98%) /some on-site travel(<3%)
- Due to our government client requirements, we can only consider US Citizen or a Green Card holders for this position
- NO THIRD PARTY RECRUITERS PLEASE!
KEYWORDS: Pharmaceutical, Clinical Systems Validation
- Develop and execute validation deliverables including, but not limited to IQ, OQ, PQ, UAT scripts and testing.
- Ensure Clients GxP computerized IT systems are tested, validated, and controlled to comply with applicable regulations and internal SOPs and policies in collaboration with Client Quality Assurance.
- Closely work with the IT Applications, IT Infrastructure, IT Security, and Quality Assurance on various projects.
- Attend daily, weekly, and monthly meetings on projects and interface directly with clients and other teams.
- 3-7 years of experience working in GLP, GCP, or GMP regulatory environment.
- Experience with Enterprise Resource Planning Systems used in regulated organizations is desired.
- Experience with Clinical Trial Management System is desired.
- Experience in working with LIMS and Laboratory Equipment and Computerized Systems is desired.
- Experience with Software Development Life Cycle is desired.
Prefer experience in some of the following focus areas:
- ERP - NetSuite, SAP, MS Dynamics, other ERP Applications
- EDC - REDCap, Medidata, other EDC applications
- LIMS - LabCollector, Freezerworks, Labware, other LIMS application
- Chromatography - Analyst, Empower, OpenLab, Chromeleon Other Chromatography Systems
- Lab Systems - MDS, SoftMax, Quant Studio, general QC Laboratory Equipment Validation
- Other - VisioPharm
- Only those individuals selected for an interview will be contacted.
- No calls, inquiries, or Third-Party Vendors please.
- We are an equal opportunity employer (Unable to sponsor H1B Visas).
- $1000 Referral Bonus - www.aci.com.
Since 1988, The ACI Group, a Baltimore-based IT staffing firm, has been committed to hiring the industrys leading professionals, and presenting exciting career opportunities. We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.