QA Documentation Lead: cGMP & MasterControl Expert

Tris Pharma, Inc.; Northern (KY); Hybrid; USD 78,000 - 102,000; Full time

Job summary

Tris Pharma, Inc. seeks a Quality Assurance Documentation Lead to support the QA function at our Monmouth, NJ location. This role ensures manufacturing quality controls and procedures align with SOPs, cGMPs, and FDA standards.

You will manage Master Control systems, stability data, and GxP records, and collaborate跨-functional teams to deliver timely APR reports and ensure compliance with quality policies.

Qualifications

• Bachelor’s degree in Chemistry, Statistics, Biology, or a related field and 3 yrs QA/ Lab/ manufacturing exp.

Responsibilities

• Support QA function to ensure manufacturing quality controls and SOP compliance.
• Maintain quality documentation in accordance with SOPs, cGMPs, and records management requirements.
• Support Master Control systems, including DCR PKTs, specs, test methods, stability protocols, MBRs, and MOC processes.
• Perform daily monitoring and documentation of stability chambers and calibration checks; report excursions or OOS.
• Issue, archive, and reconcile GxP records; ensure APR schedules and timelines are met.
• Collaborate with cross-functional teams to prepare APR sub-reports and conduct risk assessments.

Skills

cGMPs knowledge

Quality documentation

MasterControl

GxP records

MS Office

APR data reporting

Stability chambers

SLIM DB

Education

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

Tools

MasterControl

SLIM DB

MS Office

Job description

Tris Pharma, Inc. seeks a Quality Assurance Documentation Lead to support the QA function at our Monmouth, NJ location. This role ensures manufacturing quality controls and procedures align with SOPs, cGMPs, and FDA standards.

You will manage Master Control systems, stability data, and GxP records, and collaborate跨-functional teams to deliver timely APR reports and ensure compliance with quality policies.