Senior Microbiology Quality Analyst

Socket.dev; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Socket.dev in Austin, TX seeks a BQ Analyst to support manufacturing operations through routine and non-routine testing of utilities, sterilizer systems, raw materials, in-process and final products in compliance with cGMP and GDP.

You will perform microbiological testing per SLPs and SOPs, operate instruments (HIAC, SAS, spectrophotometer, LAF/BSC), maintain records in PharmSpec, MODA, Labware or similar, draft SOP changes, and assist in CAPA investigations.

Qualifications

• Bachelor’s degree in microbiology or biological sciences.
• Minimum of 4–6 years of relevant experience.
• Experience with microbiology lab methods and SOPs.
• Familiarity with cGMP, cGDP, SLPs and documentation practices.
• Proficient with Microsoft Office and LIMS software.

Responsibilities

• Perform microbiological testing per SLPs and SOPs.
• Operate and maintain lab instruments (HIAC, SAS, spectrophotometer, LAF/BSC).
• Prepare and maintain batch records and electronic lab records.
• Draft or edit SOPs, STMs, CAPAs and investigations.
• Train new staff and support timely product release with regulatory compliance.

Skills

Microbiology

Laboratory testing

SOPs & SLPs

cGMP / cGDP

Data management

LIMS

Batch records

Education

Bachelor’s degree in microbiology or biological sciences

Tools

PharmSpec

MODA

Labware

Oracle

Excel

Access

Job description

Socket.dev in Austin, TX seeks a BQ Analyst to support manufacturing operations through routine and non-routine testing of utilities, sterilizer systems, raw materials, in-process and final products in compliance with cGMP and GDP.

You will perform microbiological testing per SLPs and SOPs, operate instruments (HIAC, SAS, spectrophotometer, LAF/BSC), maintain records in PharmSpec, MODA, Labware or similar, draft SOP changes, and assist in CAPA investigations.