Bioanalytics QC Associate I

BioSpace; West Greenwich (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen Rhode Island is seeking a Quality Control Associate I - Bioanalytics to perform and review analytical testing in a cGMP data-driven lab. The role reports to the front-line manager and covers in-process, release, and stability samples using methods including HPLC/UPLC and capillary electrophoresis.

You will maintain documentation, ensure compliance, operate instruments, partake in investigations, and support continual improvement; a relevant degree or experience is required, with GMP/GDP

Qualifications

• High school diploma or GED with 2 years quality experience, or
• Associate degree with 6 months quality experience, or
• Bachelor’s Degree/Master’s Degree in a relevant science field.
• Experience with HPLC/UPLC and capillary electrophoresis is preferred.
• Experience in laboratory investigations, method validation, audits, and QC processes.
• Ability to interpret scientific data and communicate findings clearly.
• GMP/GDP experience is preferred.

Responsibilities

• Follow safety guidelines and cGMP regulations.
• Generate accurate laboratory documentation and notebooks.
• Ensure facilities and processes comply with cGMP and regulations.
• Operate laboratory equipment and instrumentation.
• Review and approve assays, documents and records.
• Support continual improvement initiatives.
• Identify and alert management to quality, compliance, supply and safety risks.
• Participate in laboratory investigations and training.

Skills

Detail orientation

Strong communication

Self-motivated

Organizational skills

GMP/GDP experience

Education

High school diploma / GED

Associate degree

Bachelor’s degree / Master’s degree

Tools

HPLC/UPLC

Capillary electrophoresis

Chemistry testing methods

Job description

Amgen Rhode Island is seeking a Quality Control Associate I - Bioanalytics to perform and review analytical testing in a cGMP data-driven lab. The role reports to the front-line manager and covers in-process, release, and stability samples using methods including HPLC/UPLC and capillary electrophoresis.

You will maintain documentation, ensure compliance, operate instruments, partake in investigations, and support continual improvement; a relevant degree or experience is required, with GMP/GDP