QC Specialist

Xyntek Inc.; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

Catalyx is seeking a QC Specialist to support the initiation, execution, and completion of deviations, investigations, quality impact assessments, or other appropriate quality-system actions.

The role requires hands-on experience with GDP and data integrity, and an ability to review laboratory documentation and records. Based in Rensselaer, United States, the position emphasizes GMP compliance and regulatory readiness for FDA inspections.

Qualifications

• Hands-on review of laboratory documentation and records.
• Strong knowledge of GDP/ALCOA+ and data integrity requirements.
• Experience identifying documentation discrepancies and GMP issues.
• Familiarity with FDA 21 CFR Parts 210 and 211.
• Experience supporting FDA inspections preferred.

Responsibilities

• Execute the retrospective review using approved client procedures and review forms.
• Apply consistent GMP and data integrity standards across all records.
• Document objective observations without rewriting historical records.
• Escalate and support findings which may require further investigation or quality assessment.
• Support the client in providing a thorough, defensible review that can withstand regulatory scrutiny.

Skills

GDP/ALCOA+ knowledge

GMP compliance

Data integrity

Documentation review

FDA regulatory familiarity

Job description

Rensselaer, United States | Posted on 08/17/2026

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai .

Job Description

Catalyx is seeking a QC Specialists to support the initiation, execution, andcompletion of deviations, investigations, quality impact assessments, or otherappropriate quality-system actions.

Responsibilities

• Executethe retrospective review using approved client procedures and reviewforms.
• Applyconsistent GMP and data integrity standards across all records.
• Documentobjective observations without rewriting historical records.
• Escalateand support findings which may require further investigation or qualityassessment.
• Supportthe client in providing a thorough, defensible review that can withstandregulatory scrutiny.

Requirements

• Hands-onexperience reviewing laboratory documentation, equipment logbooks,laboratory notebooks, and controlled records.
• Strongknowledge of Good Documentation Practices (GDP), ALCOA+ principles, anddata integrity requirements.
• Experienceidentifying documentation discrepancies, omissions, incomplete records,and GMP compliance issues.
• Familiaritywith FDA 21 CFR Parts 210 and 211 and current GMP requirements applicableto Quality Control laboratories.
• Experiencesupporting FDA inspection readiness, remediation, Warning Letter, consentdecree, or quality improvement initiatives preferred.
• Abilityto perform detailed, high-volume manual reviews of paper records whilemaintaining accuracy and consistency.
• Experiencedocumenting objective observations and escalating findings throughestablished quality systems.
• Comfortableworking within client SOPs, review forms, and established review criteria.

Why Join Catalyx?

At Catalyx we understand that our people are our greatestasset. For this reason and many others, we take care of them. The team inCatalyx benefits from a Total Rewards package. This includes great personalbenefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committedto creating a diverse and inclusive workplace where all individuals are valued,respected, and supported. We do not discriminate on the basis of race, color,religion, sex (including pregnancy, gender identity, and sexual orientation),national origin, age, disability, veteran status, genetic information, or anyother characteristic protected by applicable law. We encourage applicationsfrom all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

At Catalyx, we are committed to attracting the best globaltalent. We proudly support our international employees by offering assistancewith Critical Skills Visa applications for eligible candidates.