Quality Assurance Specialist (QMS) – CAPA & Compliance

Streck; La Vista (NE); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

No night or weekend shifts

Market competitive pay

Excellent work life balance

Comprehensive benefits

Great team environment

Career development opportunities

Job summary

Streck seeks a Quality Assurance Specialist to provide day-to-day quality support within designated departments in our Nebraska facility. You will help ensure regulatory compliance, lead CAPA activities, and support SOPs and DHR reviews.

The role requires an associate degree with 1–4 years of FDA-regulated manufacturing experience; a STEM bachelor’s is preferred. Expect a no-night-shift, team-focused environment with strong training opportunities.

Qualifications

• Associate degree required; STEM or related field preferred.
• 1–4 years of related work in an FDA-regulated manufacturing environment; 2–3 years quality experience may substitute for education.

Responsibilities

• Support investigations of observations, deviations, and nonconforming materials.
• Lead RCA meetings as part of CAPA, support CAPA plan and effectiveness checks.
• Assist with Change Control training and observation.
• Deliver quality training to new hires and ongoing sessions.
• Perform biannual audits of equipment in assigned areas.
• Collaborate with Operations to prevent errors and monitor performance.
• Assist with writing and revising SOPs and review DHRs.
• Analyze quality data and communicate trends to management.
• Participate in continuous improvement projects and validation teams.
• Support batch records, in-process checks, and inspections across functions.

Skills

MS Word

MS Excel

Attention to detail

Quality auditing

Accountability

Team oriented

Education

Associate degree

Bachelor's degree in STEM or related

Tools

Microsoft Word

Microsoft Excel

Job description

Streck seeks a Quality Assurance Specialist to provide day-to-day quality support within designated departments in our Nebraska facility. You will help ensure regulatory compliance, lead CAPA activities, and support SOPs and DHR reviews.

The role requires an associate degree with 1–4 years of FDA-regulated manufacturing experience; a STEM bachelor’s is preferred. Expect a no-night-shift, team-focused environment with strong training opportunities.