QA Documentation Lead: MasterControl & cGMP

Clay Today; Northern (KY); Hybrid; USD 78,000 - 102,000; Full time

Job summary

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to join our Monmouth, NJ site.

You will support the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards. Under QA Mgmt you will perform day‑to‑day QA activities supporting multiple departments, maintain quality documentation, and assist with Master Control systems, including DCR PKTs, specs, test methods, stability protocols, MBRs, and MOC processes.

Qualifications

• Bachelor's degree in Chemistry, Statistics, Biology, or related field.
• At least 3 years of QA, lab, or manufacturing experience in pharma/biotech.
• Strong knowledge of cGMPs, QA documentation, and MasterControl systems.

Responsibilities

• Support QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards.
• Maintain quality documentation in compliance with company policies and records management.
• Support Master Control systems and related documentation (DCR, PKTs, specs, test methods, stability, MBRs, MOC).
• Collaborate with Lab Ops, Product Dev, Tech Svcs, Eng, Production & Packaging, QA Ops, and IT.

Skills

Quality assurance

MasterControl

MS Office

Documentation control

FDA compliance

Education

Bachelor's degree in Chemistry, Statistics, Biology, or related field

Job description

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to join our Monmouth, NJ site.

You will support the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards. Under QA Mgmt you will perform day‑to‑day QA activities supporting multiple departments, maintain quality documentation, and assist with Master Control systems, including DCR PKTs, specs, test methods, stability protocols, MBRs, and MOC processes.