Senior QC Analyst – Biopharma (On-Site)

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Company-Paid Life Insurance

Disability Insurance

FSA/HSA

401(k) with company match

Paid Time Off

Paid Holidays

Job summary

Argonaut Manufacturing Services, Inc. in Carlsbad, CA, seeks an experienced QC Analyst to perform in-process, finished product, and stability testing in a GMP environment.

You will manage samples with LIMS and execute analyses using HPLC/UHPLC, FTIR, and UV/Vis, contributing to method validation and CAPA processes. This role reports to the Director of Quality Control and is on-site, with potential overtime.

Qualifications

• Undergraduate degree in Life Sciences required.
• Minimum 7 years’ GMP QC experience in medical device/biopharma.
• Experience with analytical methods and data integrity.
• Proficient in documenting with SOPs and reports.

Responsibilities

• Manage incoming samples using a laboratory information system (LIMS).
• Perform detailed chemical analysis of samples from production, stability, and validation studies.
• Utilize HPLC/UHPLC, cIEF/SDS-PAGE, FTIR, and UV/Vis instruments.
• Author protocols and reports including method qualification, verification, validation, and suitability.
• Apply data integrity principles to sample handling and analysis.
• Manage deviation/OOS investigations and implement CAPAs and change controls.
• Train junior personnel in lab and safety procedures.
• Interface with product sponsors on QC inquiries.
• Review and approve Manufacturing Batch Records for QC activities.
• Execute analytical method transfer activities for product-specific methods.

Skills

GMP experience

QC testing

HPLC/UHPLC

Data integrity

Documentation

Cross-functional teamwork

Safety procedures

Education

B.S. in Life Sciences

Tools

LIMS

HPLC/UHPLC

cIEF

SDS-PAGE

FTIR

Job description

Argonaut Manufacturing Services, Inc. in Carlsbad, CA, seeks an experienced QC Analyst to perform in-process, finished product, and stability testing in a GMP environment.

You will manage samples with LIMS and execute analyses using HPLC/UHPLC, FTIR, and UV/Vis, contributing to method validation and CAPA processes. This role reports to the Director of Quality Control and is on-site, with potential overtime.