QC Specialist

Job Description
Catalyx is seekinga QC Specialists to support the initiation, execution, and completion of deviations, investigations, quality impact assessments, or other appropriate 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 greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to 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 any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

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