qc it application analyst .

A Global Biotech Pharma Located in Lexington, MA is seeking a QC IT Application Analyst to join their Team! We are looking for a candidate who can support QCIT operations in a GMP environment, including: Developing and executing periodic validation activities (backup and restore testing, user access reviews, and audit trail reviews) Front-line client support and triage (initial assessment and coordination of repair activities when systems are down) Supporting GxP workstation patching activities Supporting decommissioning activities (for example, final backups and account deactivations) Job Description: The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development The QC IT Application Analyst manages their work with limited oversight- The scope of work includes, but is not limited to the following: Project upgrades from win 7- win 10 Provide oversight of vendor-provided solutions Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned. Work with other Direct team members for descions, and clariffications as needed  Must be able to juggle multiple projects and deliverables, and split billing time between projects where needed.  Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc. Must poses GXP experience with lab equipment. Recommended Experience  Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access, NTFS permissions. Excellent written and verbal communication. Applications impacted by upgrades, Ideal candidate should have previous experience mplementing, and or upgrading. Other application experience can be considered.  Vaya Raman  7500 Fast PCR  Hiac Particle Counters  Maldi-tof  Vi-Cell Cell counter  Antaris II Waters Andrew + Alliance Key Skills, Abilities, and Competencies IT Technology Skills & Competencies  IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments - Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bioprofile CDV and Flex2 Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS, Historians Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance  

salary: $75 - $85 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors



Responsibilities

We are looking for a candidate who can support QCIT operations in a GMP environment, including:

Developing and executing periodic validation activities (backup and restore testing, user access reviews, and audit trail reviews)
Front-line client support and triage (initial assessment and coordination of repair activities when systems are down)
Supporting GxP workstation patching activities
Supporting decommissioning activities (for example, final backups and account deactivations)

Job Description:
The QC IT Application Analyst collaborates with the business and IT teams to provide
project support for MA Biologics Operations Site Functions – Quality, Validation and
Product Development.
The QC IT Application Analyst manages their work with limited oversight-
The scope of work includes, but is not limited to the following:
 Project upgrades from win 7- win 10
 Provide oversight of vendor-provided solutions
 Handle ad-hoc technical requests from both internal and external partners in
accordance with projects that are assigned.
 Work with other Direct team members for descions, and clariffications as needed
 Must be able to juggle multiple projects and deliverables, and split billing time
between projects where needed.
 Experience with performing design testing of application to help author SDLC
documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application
Data Flow diagrams, etc.
 Must poses GXP experience with lab equipment.

The essential functions of this role include:

• working in a smoke free environment

Skills

• GMP Environment
• Backup and Restore Testing
• Audit Trail Reveiws
• Quality PRDT Development
• ad-hoc technical requests
• Data Flow diagrams
• Veeva
• TrackWise
• Supporting Quality Systems
• Support Manufacturing Systems
• MS Office 365, MS Visio, MS Pr

Qualifications

• Years of experience: 5 years
• Experience level: Experienced

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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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