QC Chemistry Associate: Startup & Validation

Amgen Inc.; Holly Springs (NC); Sur place; USD 63 000 - 85 000; Plein temps

Avantages offerts par ce poste

Retirement plan

Medical/Dental/Vision coverage

Life and disability insurance

Flexible spending accounts

Résumé du poste

Amgen in Holly Springs is seeking an Associate QC I to support the Chemistry lab startup and perform qualification and routine testing to support the facility. You will write procedures and reports, help install and qualify new lab equipment and participate in method transfers and validation.

Under minimal supervision, you will collaborate with site teams to establish systems and support GMP compliance and data integrity. Some weekend or shift work may be required as the startup progresses.

Qualifications

• 4+ years of GMP lab experience.
• Degree in chemistry, biochemistry, physics or chemical engineering.
• Experience with validation, verification and method transfer.
• Strong knowledge of laboratory techniques.
• Excellent written and verbal communication.
• Able to work in teams and adapt to shifts.

Responsabilités

• Support QC Chemistry startup activities and system qualification.
• Coordinate lab equipment work orders and PM scheduling.
• Assist with data integrity assessments for computerized lab systems.
• Review and approve QC method executions for GMP and stability.
• Assist with procurement of consumables and reagents.
• Ensure method transfer for HPLC, UPLC, TOC and related equipment.
• Participate in audits and interdepartmental projects.
• Support weekend and holiday activities as needed.

Connaissances

Laboratory techniques

Regulatory knowledge

Technical writing

Validation & transfer

Teamwork

Communication skills

Formation

Bachelor's degree in science

Outils

LIMS

LMES/CIMS

Description du poste

Amgen in Holly Springs is seeking an Associate QC I to support the Chemistry lab startup and perform qualification and routine testing to support the facility. You will write procedures and reports, help install and qualify new lab equipment and participate in method transfers and validation.

Under minimal supervision, you will collaborate with site teams to establish systems and support GMP compliance and data integrity. Some weekend or shift work may be required as the startup progresses.