IRT Test Analyst

🕒 July 28

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 49%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Sharp Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

💊 Pharmaceuticals

💰 $712.5M Debt Financing on 2022-01

Healthcare • Consulting • Pharmaceuticals

Sharp Services is a leader in pharmaceutical packaging, clinical trial supply services, and small-scale sterile manufacturing, with a heritage spanning more than 70 years. The company partners with pharmaceutical and biotechnology clients, offering solutions and support from phase I trials all the way through to commercial launch and lifecycle management. Their 2,200+ strong team leverages capabilities in state-of-the-art GMP facilities in the US, UK, Belgium, and the Netherlands.

📋 Description

• Write test plans in accordance with GAMP 5 and software methodologies • Create use and/or test cases based on requirements specifications and test plans • Execute approved test cases • Maintain an issues log of errors noted during test execution • Create testing summaries and work with the IRT Project Manager on resolution plans • Communicate testing status to the project team • Maintain testing documentation • Review and provide input on requirement specifications, focusing on patient safety and data integrity risks • Conduct peer reviews of test cases and testing documentation • Assist the IRT Project Manager with testing timelines and Client Acceptance Testing setup • Ensure timely delivery of project-related deliverables and escalate timeline risks • Assist in maintaining the IRT Project File • Adhere to Standard Operating Procedures and Work Instructions • Contribute subject matter expertise to create or update Standard Operating Procedures • Prepare for and participate in internal/external audits and regulatory investigations • Participate in Quality Investigations • Initiate Quality Events as defined in Standard Operating Procedures • Serve as the primary subject matter expert for software testing

🎯 Requirements

• Experience with computer systems and software application implementation, including knowledge of software development life cycle • Strong communication skills for communication with internal stakeholders and vendors • Basic knowledge of SQL, XML Web services, sFTP and SAS • Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point • Bachelor’s degree or equivalent work experience • 2-3 years’ experience in a similar quality management or testing role • 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects • Experience using IRT, EDC, or ePRO Systems • Knowledge of the clinical research industry, standard practices, GHC, ICH/GCP guidelines and FDA Regulations • Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11

🏖️ Benefits

• Full-time employment • Remote/field-home-based work arrangement