QC Laboratory Systems Analyst GxP CSV W2 Only

Quantive Intelligence; Lexington (MA); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Quantive Intelligence is seeking a QC Laboratory Systems Analyst to support GMP/CSV environments in Lexington, MA onsite. The role focuses on validation testing, backup and restore activities, user access reviews, and audit trail reviews within a 100% on-site setup.

The candidate will collaborate with QA, Validation and Product Development teams, manage upgrades and vendor-provided solutions, and handle ad-hoc IT requests while maintaining SDLC documentation and GxP lab equipment compliance.

Qualificações

• More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)
• Experience with software application implementations in GxP environment (required)
• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration
• Experience in Pharmaceuticals or Life Sciences industry (preferred)
• Experience consulting or working in a complex, global matrix organization (preferred)
• Knowledge of Lean operational techniques (preferred)

Responsabilidades

• Collaborate with the business and IT teams to support MA Biologics Operations Site Functions—Quality, Validation and Product Development.
• Manage work with limited oversight and multi-project delivery.
• Perform design testing of applications to support SDLC documents (URS, FRA, IQ/OQ, DFs, etc.).
• Oversee upgrades (e.g., Windows 7 to Windows 10) and vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners.
• Ensure GxP lab equipment compliance and data integrity.

Conhecimentos

GxP experience

CSV compliance

ITIL processes

Documentation SDLC

Vendor coordination

Formação académica

Bachelor's degree in IT/CS/Engineering or Business Administration

Ferramentas

ServiceNow

TrackWise

Veeva

Descrição da oferta de emprego

Job Description

Job Description

QC Laboratory Systems Analyst – GxP / CSV– 100% On Site – W2 Only – BB10346

12 Month contract with potential to extend

Onsite Expectations: 5 days a week ONSITE.

Lexington, MA

Overall

• 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, Idele candidate should have previous experience implementing, 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

Education and Experience Requirements

More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)

• Experience with software application implementations in GxP environment (required)
• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration,
• Experience in the Pharmaceuticals or Life Sciences industry (preferred)
• Experience consulting or working in a complex, global matrix organization (preferred)
• Knowledge of Lean operational techniques (preferred)

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, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GxP environment
• 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
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with following tools and processes –
• TrackWise – CAPA, Deviation, Change Control
• Veeva – Document Workflows
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity of following Tools and technologies
• MS Office 365, MS Visio, MS Project
• Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
• Architectures – 2 Tier, 3 Tier, On-premise, Cloud

Physical Demands

• Must be able to lift, push, pull and carry up to 30 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
• Must be able to work in controlled environments requiring special gowning. Will potentially be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tabaco, candy etc. may be used in the QC / Manufacturing environment.
• During onboarding and training Onsite requirement will be 5 days per week.
• Afterwards minimum 3-4 days a week onsite is required.
• Must be able to work overtime as required.
• May be required to work in a confined area

TechData is now a part of Quantive Intelligence, same people, expanded capabilities and we are proud to be an equal opportunity workplace and an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.