GMP QC Analyst - Biotech Method Transfer

USDM Life Sciences; Thousand Oaks (CA); On-site; USD 55,000 - 83,000; Full time

Benefits offered by this job

Health insurance

Vision/Dental insurance

401(k) plan

Paid time off

Rewards and recognition program

Job summary

USDM Life Sciences is seeking a QC Analyst to support the QC department in a cGMP environment. You will conduct analyses on raw materials, in-process and final product samples, and environmental monitoring samples.

You will drive new methodologies in QC, assist investigations of nonconformances, manage test data review, and draft SOPs while supporting validation deliverables in a fast-paced life sciences setting.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology or Biological Sciences required or strongly preferred.
• Minimum 2 years of related work experience in quality operations, biotechnology, pharmaceutical or GMP manufacturing environment preferred.
• Experience with cGMP environment and quality control processes is desirable.

Responsibilities

• Execute biological, chemical, and physical analyses on raw materials, in-process samples, drug substances and final products.
• Drive implementation of new methodologies or sample types into existing QC methods.
• Support investigation of nonconformances and troubleshoot unexpected results.

Skills

Lab safety

Analytical methods

Lab equipment troubleshooting

FDA regulations knowledge

GMP knowledge

Investigation reports

Education

Bachelor’s Degree in Chemistry, Microbiology or Biological Sciences

Tools

HPLCs

Plate readers

LIMS

Job description

USDM Life Sciences is seeking a QC Analyst to support the QC department in a cGMP environment. You will conduct analyses on raw materials, in-process and final product samples, and environmental monitoring samples.

You will drive new methodologies in QC, assist investigations of nonconformances, manage test data review, and draft SOPs while supporting validation deliverables in a fast-paced life sciences setting.