QC Microbiology Analyst II – GMP Testing & Bioburden

Innova Solutions Inc; Woburn (MA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Medical & Pharmacy coverage

Dental & Vision insurance

401(k)

Job summary

Innova Solutions is hiring a QC Analyst II in Woburn, MA to support a gene therapy program through GMP microbiology assays including endotoxin, bioburden, TOC and growth promotion. The role involves routine testing, data review, and supporting deviations and CAPA.

Requirements include a BS/MS in Microbiology with 2+ years of industry experience and hands-on microbiology testing. Proficiency with computerized systems, Excel and Word is expected.

Qualifications

• BS or MS in Microbiology or a related discipline with 2+ years industry experience.
• QC GMP experience required.
• Hands-on microbiology testing (bioburden, endotoxin, TOC) required.
• Proficient in the use of computerized systems.
• Experience with Excel and Word.

Responsibilities

• Performs routine Quality Control microbiology testing of product and water samples (bioburden, endotoxin, TOC, growth promotion).
• Conducts review of GMP analytical data.
• Supports routine laboratory operations (data management, equipment cleaning, inventory control, logbook management).
• Ensures laboratory readiness and assists with troubleshooting/continuous improvement as needed.
• Revise SOPs, forms, protocols, data reports, and other controlled documents.
• Performs peer review of data (internal and external).
• Supports QC deviations, investigations, root cause analysis, change control, and CAPA as needed.

Skills

Bioburden testing

Endotoxin testing

TOC testing

Growth promotion

GMP documentation

Education

BS/MS in Microbiology

Tools

MS Excel

MS Word

LIMS

Job description

Innova Solutions is hiring a QC Analyst II in Woburn, MA to support a gene therapy program through GMP microbiology assays including endotoxin, bioburden, TOC and growth promotion. The role involves routine testing, data review, and supporting deviations and CAPA.

Requirements include a BS/MS in Microbiology with 2+ years of industry experience and hands-on microbiology testing. Proficiency with computerized systems, Excel and Word is expected.