QC IT Application Analyst
Intellectt INC
Hiring: QC IT Application Analyst
Industry: Pharmaceutical / Life Sciences
Location: Lexington, MA (100% Onsite)
Duration: 12+ Months
Rate: $65 $69/hr W2
About the Role:
We are seeking a QC IT Application Analyst to support Quality Control IT operations within a GMP-regulated pharmaceutical environment. This role will provide application support, validation support, and technical oversight for laboratory systems and GxP applications.
Key Responsibilities:
Support GxP systems, QC applications, and laboratory technology platforms.
Perform computer system validation (CSV) activities, including periodic reviews, user access reviews, audit trails, and backup/restore testing.
Support SDLC documentation including URS, IQ, OQ/IOQ, validation reports, SOPs, and data flow documentation.
Provide troubleshooting and technical support for QC laboratory applications and systems.
Support lab instrument applications and ensure compliance with 21 CFR Part 11 and data integrity requirements.
Manage incidents, changes, and system requests using IT service management processes.
Collaborate with Quality, IT, Laboratory, and business teams to maintain compliant operations.
Required Skills:
5+ years of IT/Application Support or Business Systems Analyst experience in pharmaceutical or GxP environments.
Experience with Computer System Validation (CSV) and regulated systems.
Knowledge of 21 CFR Part 11, GMP/GxP compliance, and data integrity principles.
Experience with laboratory applications such as Empower, Chromeleon, LabX, or similar systems.
Experience with systems including ServiceNow, TrackWise, Veeva, Active Directory, or related platforms.
Strong documentation, troubleshooting, and communication skills.
Salary:
The hourly rate for these positions is $65 $69/hr W2 based on experience and qualifications.
Benefits:
This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States.
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