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

Responsibilities

• 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.

Requirements

• 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.

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

Please Note:

• 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.