Quality Control Technical Consultant

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 scope of work includes, but is not limited to, project upgrades from Win 7 to Win 10, providing oversight of vendor-provided solutions, handling ad-hoc technical requests, and working with other direct team members for decisions and clarifications.

Must be able to juggle multiple projects and deliverables, and split billing time between projects where needed.

Key Skills, Abilities, and Competencies

• IT Technology Skills & Competencies
• Deploying and supporting Quality and Manufacturing Systems including Analytical Instruments
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
• Experience 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
• 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

Education and Experience Requirements

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

Working Environment

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.

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. May be required to work in a confined area.

Onboarding and Training

Onsite requirement will be 5 days per week during onboarding and training. Afterwards, minimum 3-4 days a week onsite is required. Must be able to work overtime as required.