Quality Assurance Specialist – QMS & CAPA

Streck, Inc.; La Vista, Northern (NE, KY); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Streck is seeking a Quality Assurance Specialist to provide day-to-day quality support within FDA-regulated manufacturing environments, driving compliance and continuous improvement. This role leads CAPA activities, supports investigations, and partners with Operations to maintain robust DHRs and batch records.

Based in a climate-controlled laboratory in Nebraska, you will perform audits, write SOPs, train staff, and help ensure product quality from development through distribution.

Qualifications

• Associate degree required; Bachelor's degree in a STEM or related discipline preferred.
• 1–4 years of related work experience in an FDA-regulated manufacturing environment; 2–3 years in quality may substitute for technical education.
• Strong PC skills with Word and Excel; quality auditing certification preferred.

Responsibilities

• Support investigation and documentation of observations, deviations, and Nonconforming Product/Material Reports.
• Lead Root Cause Analysis (RCA) meetings as part of CAPA process and assist with CAPA plan implementation.
• Assist with Change Control training and direct observation.
• Deliver quality training to new hires and ongoing training as needed.
• Perform biannual audits of equipment and review Device History Records (DHRs).
• Write and revise SOPs; analyze quality data and communicate trends to management.

Skills

Microsoft Word

Microsoft Excel

Attention to detail

Education

Associate degree

Bachelor's degree in STEM

Tools

QMS / Quality management software

Job description

Streck is seeking a Quality Assurance Specialist to provide day-to-day quality support within FDA-regulated manufacturing environments, driving compliance and continuous improvement. This role leads CAPA activities, supports investigations, and partners with Operations to maintain robust DHRs and batch records.

Based in a climate-controlled laboratory in Nebraska, you will perform audits, write SOPs, train staff, and help ensure product quality from development through distribution.