North Chicago, North Chicago

Posted 4 months ago

41 views

Unlock Premium - Save Jobs, Set Alerts & Get Early Access

Job Description

Manage projects related to laboratory instrumentation (e.g. Installation, Calibration, Qualification, Decommission, Instrument Moves), Data Integrity (DI) and computerized aspects of instrument support, Controlled Storage (e.g. Chamber Profiling, Alarm Monitoring), and ancillary lab systems (e.g. water, monitoring systems, utilities, etc.).
Author, review, and/or contribute to quality related documentation, including experimental protocols, results summaries, Standard Operating Procedures (SOPs), and software configuration documents as needed.
Collaborate and/or coordinate with internal and external partners (e.g. Laboratory Personnel, Quality Assurance (QA), Concierge Services (CS), Validation Review Board (VRB), BTS (IT), third-party contractors, external vendors) to maintain alignment on project scope, timelines, and deliverables.
Manage and multitask instrument activities to support the pipeline and escalate concerns appropriately. Ensure that critical lab priorities are delivered in a timely manner to support pipeline activities.
Maintain a deep knowledge of instrument processes and support process improvement updates where needed.
Participate in preparation for and support of audits on instrumentation and data integrity topics, including follow-on activities.
Maintain activities supported by ARD LC IMT (e.g. Out of Tolerance (OOT), instrument inventory, instrument scheduler, red stickers).
Support other cGMP quality activities within function as needed.

May have opportunity to lead, develop, and coach temporary workers and summer interns.

Drives/coordinates operational decision making on a site basis.
Adapts to changing environments and balances priorities.
Supports project development of technological innovations by providing guidance on regulatory / cGMP expectations for novel analytical instrumentation.

Builds strong relationships with peers to create and implement cross-departmental operational strategies.
Knows the business to influence long-range strategies.
Creates a learning environment, open to suggestions and experimentation.
Deals comfortably with uncertainty, ambiguity, and risk ensuring alignment with corporate/regulatory policies/standards.
Raises the bar and drives the function to efficient/reliable execution.
Learns fast, grasps the essence and can change course quickly where indicated.

Skills & Technologies

Python R MATLAB Data Integrity cGMP FDA EMA Calibration Qualification Standard Operating Procedures (SOPs)

Explore Sports Tech Careers

Discover exciting opportunities in sports technology. Join innovative companies transforming the sports industry through data, media, and cutting-edge tech.

Remote FriendlyCompetitive SalarySports Tech

Explore Sports Tech Jobs Learn More

Salary Information

Salary: $95000-125000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

Browse all biotech salaries →