Hi I hope you are doing well. I am sending the new requirement, please go through it and let me know if you are comfortable.
*Need :Manual QA Tester (Pharma)Location: Cambridge, MADuration: 6-12 months* *Rate Max: $38/C2C * ***********A MANUAL TESTER WITH PHARMA BACKGROUND******* *Description:* Writing test scripts and test cases. All scripts are done manually. Some interaction with users to understand what the system is doing and what it should be doing. *PQ Scripts is* required. LIMS is required. *Profile:* The Analyst is a member of the IT project teams with a special focus on understanding the business, laboratory and documentation processes for Companion Diagnostics. The ideal candidate will utilize technical knowledge, business knowledge, analytical skills and compliance knowledge to assess, define, implement and support IT systems for the department including Quality Management System (QMS) and Laboratory Information Management System (LIMS). *Responsibility:* Develop sufficient system (LIMS) expertise to be able identify issues (i.e. software bugs, configuration etc.) that require resolution. Assess system readiness by confirming resolution of all issues Author and support creation of validation scripts including PQ, OQ Collaborate with Project Quality Manager and business to develop project deliverables such as Traceability Matrix, Functional Risk Assessment, Performance Qualification (UAT), etc. Ensure implemented solutions are according to specifications and fit for purpose Experience/Professional requirements: Minimum of BS degree or equivalent in Business Administration, Computer or Life Sciences with at least 5 years of experience within IT group of biotech, pharmaceutical or research environment. Experience writing test scripts for software validation. Experience with Laboratory Information Management Systems such as Labvantage, Labware, Watson or others. Familiarity with Quality Management Systems (QMS) such as EtQ, Pilgrim/SmartSolve, Paradigm 3, TrackWise, MQ1, etc. is a plus Understanding of GxP (GMP/GLP/GDP) environments and health authority requirements for system validation. Familiarity with formal project methodology (e.g., CMM, Catalyst, Six Sigma, RUP, etc.). Ability to work effectively in a highly matrixed team environment. Good written, verbal and presentation skills, facilitation, negotiation, and problem resolution skills required. Fluent in English -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Thanks&Regards James Miller | IT Recruiter ITBrainiac Inc, Princeton, NJ 08540 Direct: (609-935-3773)*101 | Fax 312.582.2699 Website:www.itbrainiac. Yahoo :james.usrecruiter Gtalk :james.usrecruiter Email : [email protected] Notice: This email contains confidential or proprietary information which may be legally privileged. It is intended only for the named recipient (s). If an.addressing or transmission error has misdirected the email, please notify the author by replying to this message. If you are not the named recipient, youare not authorized to use, disclose, distribute, copy, print or reply on this email, and should immediately delete it from your computer system list
