QA Manual tester  with Pharma exp in MA for 6-12 months Contract!!

Title: Manual QA Tester (Pharma)

Location: Cambridge, MA

Duration: 6-12 month contract

LIMS is required.

*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

Regards
Rachel Lian
Technical Recruiter
Desk No :201-855-4204 IT Brainiac Inc-
[email protected] |
Gmail:[email protected]
www.itbrainiac.com
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