QA Documentation Lead — cGMP & FDA Compliance

Tris Pharma; South Brunswick (NJ); On-site; USD 78,000 - 102,000; Full time

Job summary

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead at our Monmouth, NJ location. The role supports the QA function to ensure manufacturing quality controls, SOPs, cGMPs and FDA standards are met.

Responsibilities include maintaining quality documentation, supporting MasterControl systems, conducting stability chamber monitoring, preparing APR data, and coordinating with cross-functional teams to ensure timely, compliant sub-reports. Fluency in English required.

Qualifications

• Bachelor’s degree in Chemistry, Statistics, Biology, or related field with 3 years QA/lab/manufacturing experience in pharma/biotech.
• 3 years working knowledge of cGMPs and maintaining quality documentation per SOPs and cGMPs.
• Experience with MasterControl systems and documentation control (DCR PKT, specs, test methods, SPTM).
• Daily handling of GxP records, archiving, reconciliation, and documents control.
• Proficient with SLIM DB, stability sample pulls, transfers, and custody records.
• Experience compiling APR data and presenting reports for resin-based tablets/powders.

Responsibilities

• Support and assist the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards.
• Maintain quality documentation in compliance with company policies, SOPs and records-mgmt requirements.
• Support Master Control systems and APR-related activities; ensure timely, compliant sub-reports.
• Monitor stability chambers, document excursions, and notify QA Stability Mgmt of discrepancies.
• Collaborate with cross-functional teams to ensure accuracy and compliance of APR reports.

Skills

QA knowledge

cGMP experience

Quality documentation

SOP adherence

APR reporting

Stability data analysis

Team collaboration

Education

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

Tools

MasterControl

SLIM DB

MS Office

Job description

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead at our Monmouth, NJ location. The role supports the QA function to ensure manufacturing quality controls, SOPs, cGMPs and FDA standards are met.

Responsibilities include maintaining quality documentation, supporting MasterControl systems, conducting stability chamber monitoring, preparing APR data, and coordinating with cross-functional teams to ensure timely, compliant sub-reports. Fluency in English required.