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QA Specialist
Job in
Franksville, Racine County, Wisconsin, 53126, USA
Listed on 2026-02-05
Listing for:
CSL USA Inc.
Full Time
position Listed on 2026-02-05
Job specializations:
-
Quality Assurance - QA/QC
Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager, Data Analyst
Job Description & How to Apply Below
GENERAL PURPOSE OF JOB
The QA Specialist (QAS) works within the Quality Assurance Department. This role participates in programs to ensure compliance with 21 CFR 117, 21 CFR 111, internal standards, FSSC 22000, and other certifications, while applying industry practices. It is a dual-role position, combining daily hands-on quality inspection in production as needed and office-based QA responsibilities, including product release, documentation, supplier qualification, auditing, investigation, and continuous improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Conduct daily PCQI review of batch production records and QC records for completeness and accuracy for finished product release and coordinate timely corrections. Generate Certificates of Analysis (COAs) using ERP.
- Coordinate supplier qualification and performance monitoring for ingredients, ingredient sampling, packaging, in-bound packaging inspection, label review, and services; initiate hazard analysis for HACCP; interpret Specifications and Certificates of Analysis to support other functions.
- Coordinate or administer the Document Control Program, including review for compliance with internal and regulatory standards, and formatting, approval routing, publishing. Coordinate periodic review process.
- Coordinate or administer Kosher and Halal certification programs, ensuring documentation is current
- Support or coordinate Quality Systems programs:
Deviation Management, CAPA, Change Control, Complaint Handling, Product Hold/Release, Internal Audits, and Customer Technical Documentation. - Participate in developing and verifying procedures documentation, and specifications to ensure compliance with 21 CFR 111
, 21 CFR 117
, and FSSC 22000 standards, through interpretation, collaboration, and internal audits. - Participate in FSSC 22000 programs, including HACCP/Food Safety Team, Food Defense, Fraud Mitigation, Traceability, and Mock Recalls, by providing documentation, process knowledge, and verification support
- Participate in or lead root cause investigations of deviations, complaints, audit findings, and quality issues
- Develop and implement training programs for GMP, GDP, HACCP, food safety, and job-specific responsibilities; assist in monitoring and tracking completion of training
- Support KPI tracking and quality reports for Management Reviews; create reports with Excel, Word, PowerPoint.
- Assist with regulatory, certification, customer audits; ensure readiness; facilitate responses and corrections.
- Perform in-process inspections during probiotic and dietary supplement manufacturing and packaging to ensure compliance with GMP, batch records, and process controls.
- Conduct line clearance, start-up verification, and end-of-run reconciliations, ensuring documentation accuracy and process integrity.
- Monitor and support GMP compliance on the floor, including verification of sanitation, material handling, production and maintenance practices and records for adherence to MMRs, SOPs, and internal standards
- Support floor-based inspections, investigations, non-conformance handling, and product containment
- Collaborate with cross-functional teams—including Production, Supply Chain, and Procurement—to resolve issues related to batch discrepancies, incoming material quality, and supplier corrective actions.
- Contribute to continuous improvement by providing quality input during troubleshooting and process reviews.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE- Bachelor’s degree in Food Science, Microbiology, Biology, Chemistry, or a related field preferred, or equivalent education and experience combination
- 1+ years Quality (QA/QC) experience in dietary supplements, food, or pharmaceutical manufacturing
- Working knowledge of…
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