Quality Analyst I — GMP/ISO, Medical Devices & Tissue

Actalent; Vandalia (OH); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance (Voluntary)

Job summary

Actalent is seeking a Quality Analyst to perform quality control inspections and dispositions in a Vandalia, OH facility. You will support lot release activities, manage CAPA/NCR/Deviation records, and contribute to continuous improvement of quality processes in a state-of-the-art environment.

The role requires a Life Science degree and 1–2 years of experience in GMP/GDP/GxP; familiarity with FDA, OSHA, ISO standards, and GDP practices is preferred.

Qualifications

• Bachelor’s degree in Life Science or related field.
• 1–2 years GMP/GDP/GxP in medical device, tissue, or pharma preferred.
• Experience in FDA-regulated environment preferred.

Responsibilities

• Review batch production and manufacturing records for lot release.
• Coordinate CAPA, NCR, and Deviation records.
• Monitor site environmental testing program.
• Support root cause analysis for quality events.
• Release quarterly environmental monitoring reports and escalate major trends.
• Provide QMS support to CGMP departments.

Skills

GxP experience

FDA-regulated environment

CAPA/NCR/Deviations

Microsoft Excel

SOPs/Work Instructions

Regulatory knowledge

Attention to detail

Education

Bachelor’s degree in Life Science

Tools

Microsoft Excel

Job description

Actalent is seeking a Quality Analyst to perform quality control inspections and dispositions in a Vandalia, OH facility. You will support lot release activities, manage CAPA/NCR/Deviation records, and contribute to continuous improvement of quality processes in a state-of-the-art environment.

The role requires a Life Science degree and 1–2 years of experience in GMP/GDP/GxP; familiarity with FDA, OSHA, ISO standards, and GDP practices is preferred.