QC Specialist

Catalyx • Town of East Greenbush, NY

8d

About The Position

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.

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.
• 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.

Nice To Haves

• Experience supporting FDA inspection readiness, remediation, Warning Letter, consent decree, or quality improvement initiatives.

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.

Benefits

• Total Rewards package
• Personal benefits
• Professional growth opportunities
• Assistance with Critical Skills Visa applications for eligible candidates

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed