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.