QC Specialist

• 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.

Requirements

• Hands-on experience reviewing laboratory documentation, equipment logbooks, laboratory notebooks, and controlled records.
• Strong knowledge of Good Documentation Practices (GDP), ALCOA+ principles, and data integrity requirements.
• Experience identifying documentation discrepancies, omissions, incomplete records, and GMP compliance issues.
• Familiarity with FDA 21 CFR Parts 210 and 211 and current GMP requirements applicable to Quality Control laboratories.
• Experience supporting FDA inspection readiness, remediation, Warning Letter, consent decree, or quality improvement initiatives preferred.
• Ability to perform detailed, high-volume manual reviews of paper records while maintaining accuracy and consistency.
• Experience documenting objective observations and escalating findings through established quality systems.
• Comfortable working 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.