QC Technical Services Manager - GMP Instrument Lifecycle

Curium Pharma; Maryland Heights (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

Curium is seeking a Manager of Quality Control Technical Services to lead end-to-end lifecycle management of QC lab instruments and computerized systems in a GMP environment. The role covers Maryland Heights, MO, and Noblesville, IN, supervising three staff at MD Heights and one at Noblesville.

You will oversee preventative and demand maintenance, manage external service providers, author validation protocols and control changes, and ensure data integrity and regulatory compliance across US and

Qualifications

• Bachelor's degree in Chemistry or related science field is preferred.
• 12+ years of QC lab operations or related regulated environment experience.
• 2+ years of supervisory experience required.
• Strong knowledge of GMP, data integrity, calibration and lifecycle management.

Responsibilities

• Oversee preventive and demand maintenance on QC instruments and equipment.
• Manage outside service providers and service contracts.
• Author/approve analytical methods and IQ/OQ/PQ protocols and change controls.
• Ensure data integrity and regulatory compliance across US and international guidelines.
• Lead Change Controls, CAPAs, deviations and audits; supervise staff across two sites.

Skills

GMP compliance

Data integrity

Analytical instrumentation

Project management

Vendor management

SOP authoring

ALARA safety

Cross-functional collaboration

Education

Bachelor of Science in Chemistry

Tools

LIMS

Job description

Curium is seeking a Manager of Quality Control Technical Services to lead end-to-end lifecycle management of QC lab instruments and computerized systems in a GMP environment. The role covers Maryland Heights, MO, and Noblesville, IN, supervising three staff at MD Heights and one at Noblesville.

You will oversee preventative and demand maintenance, manage external service providers, author validation protocols and control changes, and ensure data integrity and regulatory compliance across US and