Quality Assurance (QMS) Specialist

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

About Streck :Streck is aNebraska-basedmanufacturing company that makes a global impactbydeveloping anddistributing tolabs worldwide. Ourproductsprovide confidenceforaccuratehealth caretesting! Ourpassions andpriorities are focusedontaking care ofour customers,employees,andgiving back to ourcommunity. Streck has jobsfor every stage ofyourcareer.If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for youto join ourcommunity of passionate people on amission!

The Opportunity

This position is responsible for quality activities performed within assigned department(s) and for helping ensure compliance with regulatory requirements and internal procedures. Working under general supervision, the Quality Assurance Specialist provides day-to-day quality support to designated departments and serves as a quality leader within their area of responsibility.

What You'll Do

• 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.

What We're Looking For

Education & Experience

• 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.

Skills & Attributes

• Strong PC skills, including proficiency with Microsoft Word and Excel.
• High attention to detail.
• Quality auditing certification preferred.
• Accountability, customer focus, professionalism, quality orientation, and a strong team focus.

This role is based in a climate-controlled biological/chemical laboratory, with occasional short-duration exposure to cold temperatures in walk-in coolers. The role requires the ability to wear required cleanroom and personal protective equipment for up to two and a half hours consecutively, and involves standing, walking, lifting up to 55 lbs occasionally, and other physical activity described in the full job description. Travel is estimated at up to 5%.

Streck is an EqualEmploymentOpportunityEmployer/Individuals with Disabilities & Protected Veterans/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.