Quality Control Technical Consultant

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)

• 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 to Win 10
• Provide oversight of vendor‑provided solutions
• Handle ad‑hoc technical requests from both internal and external partners in accordance with assigned projects
• Work with other Direct team members for decisions, and clarifications 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 the application to help author SDLC documents, including SDCS, URS, FRA, Admin SOP, IQ, IOQ, ATR, Application Flow diagrams, etc.
• Must have GxP experience with lab equipment

• IT Technology Skills & Competencies
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, Client Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche Light Cycler 480, File Maker Pro, Bartender, Charles River Endo Scan‑V, Client DataPro2, InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, Perkin Elmer Asset Genius, Thermo Web Admin for Tru Scan RM Analyzer, and various Laboratory desktop applications used in GxP environment.
• Familiarity with Automation systems such as SCADAs, PLCs, DCS, Client Historian
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
• Experience working with ITIL processes in Service Now such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with Track Wise – CAPA, Deviation, Change Control Veeva – Document Workflows
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity of 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

• 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 makeup, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tobacco, 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.

• 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)