QC Chemistry Startup Lead: Validation, Transfers & Compliance

Amgen Inc.; Holly Springs (NC); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to support initial lab start-up, qualification, and routine testing in the QC Chemistry lab. You will write procedures and reports, manage system transfers, and help implement computerized systems, with potential weekend work.

The role reports to the Director of Quality Control and requires collaboration across site teams to ensure successful training, validation, and change control processes in a GMP environment.

Qualifications

• Bachelor's degree in a related scientific field.
• 4+ years of GMP laboratory experience preferred.
• Experience with QC Chemistry/start-up activities.
• Strong written and verbal communication skills.

Responsabilités

• Lead QC Chemistry start-up activities including system qualification and validation and method transfers.
• Collaborate with site teams to establish work order and PM system for laboratory equipment.
• Review validation documents to support equipment and computerized system onboarding.
• Create and contribute to Data Integrity Assessments for computerized lab systems.
• Author, revise and review SOPs, test methods, safety assessments, trend reports, qualification/validation reports.

Connaissances

Quality control

Analytical testing

Technical writing

Team collaboration

Formation

Bachelor's degree in Chemistry or related field

Outils

LIMS

LMES/CIMS

Description du poste

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to support initial lab start-up, qualification, and routine testing in the QC Chemistry lab. You will write procedures and reports, manage system transfers, and help implement computerized systems, with potential weekend work.

The role reports to the Director of Quality Control and requires collaboration across site teams to ensure successful training, validation, and change control processes in a GMP environment.