QC Analyst, Microbiology & GMP Compliance

Bristol Myers Squibb; Bothell (WA); On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing programs

401(k) plan

Insurance protections

Job summary

Bristol Myers Squibb is seeking a QC Specialist to support testing of in-process, final product, and stability samples, plus data verification and GMP documentation reviews in a fast-paced environment.

You will train and mentor colleagues on QC methods, identify deviations, and contribute to continuous improvement initiatives while ensuring compliance with regulatory standards at the Bothell site.

Qualifications

• Regulatory compliance with cGMP requirements.
• Experience in technical writing preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers about task status, roadblocks, and needs.

Responsibilities

• Perform routine testing of in-process, final product and stability samples.
• Perform data verification, data review, and review of GMP documentation for general and complex methods.
• Perform document revision.
• Identify opportunities for continuous improvement.
• Identify and initiate deviations, CAPA’s and Laboratory Investigation.
• Train and mentor others on QC test methods, processes, and procedures.
• Perform other tasks as assigned.

Skills

Regulatory compliance

Technical writing

Problem solving

Communication

LIMS ELN analysis

Education

Bachelor’s degree or equivalent

Job description

Bristol Myers Squibb is seeking a QC Specialist to support testing of in-process, final product, and stability samples, plus data verification and GMP documentation reviews in a fast-paced environment.

You will train and mentor colleagues on QC methods, identify deviations, and contribute to continuous improvement initiatives while ensuring compliance with regulatory standards at the Bothell site.