Quality Assurance Specialist – CAPA & Process Improvement

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

Benefits offered by this job

Safe work environment

No night or weekend shifts

Excellent work life balance

Market competitive pay

Comprehensive benefits

Great team environment

Career development opportunities

Job summary

Streck, LLC in Nebraska is seeking a Quality Assurance Specialist to provide day‑to‑day QA support within designated departments, ensuring compliance with regulatory requirements and internal procedures.

You will lead root cause analysis, CAPA, SOP updates, data analysis, and training, while collaborating with Operations to prevent errors and support continuous improvement initiatives. The role includes travel up to 5% and offers a stable, team‑oriented environment.

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; relevant quality experience (2–3 years), preferably in an FDA or USDA industry, may substitute for technical education.
• Experience in FDA or USDA industry preferred.

Responsibilities

• Support investigation and documentation of observations, deviations, and Nonconforming Product/Material Reports, helping identify potential gaps in the quality system.
• Lead Root Cause Analysis (RCA) meetings as part of the Corrective and Preventive Action (CAPA) process, and assist with CAPA plan implementation and effectiveness checks.
• Support implementation of process changes arising from Change Control through training and direct observation.
• Deliver quality training to new hires and provide ongoing training as needed.
• Perform biannual audits of equipment in assigned areas.
• Maintain visibility into operations through routine direct observation, partnering closely with Operations staff on error prevention.
• Assist with writing and revising Standard Operating Procedures (SOPs).
• Collect and analyze quality data and metrics, and help communicate trends to management.
• Participate in continuous improvement initiatives and project validation teams.
• Support review and retention of Device History Records (DHRs).
• Depending on area of assignment, perform batch record and lot file reviews, in-process and final quality checks, packaging line clearance checks, and related inspections across Manufacturing, Fill/Label, Distribution, QC, QC Lab, and/or BCT Facility functions.

Skills

Attention to detail

Quality orientation

Team player

Professionalism

Customer focus

PC skills

Education

Associate degree

Bachelor's degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Streck, LLC in Nebraska is seeking a Quality Assurance Specialist to provide day‑to‑day QA support within designated departments, ensuring compliance with regulatory requirements and internal procedures.

You will lead root cause analysis, CAPA, SOP updates, data analysis, and training, while collaborating with Operations to prevent errors and support continuous improvement initiatives. The role includes travel up to 5% and offers a stable, team‑oriented environment.