QA Documentation Lead — Pharma Compliance & MasterControl

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

Benefits offered by this job

Comprehensive benefits

Job summary

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to support the QA function for cGMP-compliant manufacturing and FDA standards. The role focuses on maintaining quality records, monitoring stability chambers, and ensuring proper change control processes are followed.

You will collaborate with Lab Ops, Product Dev, Eng, Production, QA Ops, and IT to ensure timely, accurate APR sub-reports and strict conformance to SOPs and company policies. Fluency in English is required.

Qualifications

• Bachelor’s degree in Chemistry, Statistics, Biology, or related field.
• 3+ years QA, lab, or manufacturing exp in pharma/biotech.
• Familiarity with MasterControl and change control processes.
• Experience with stability chambers and documentation practices.

Responsibilities

• Support QA to ensure manufacturing quality controls comply with SOPs, cGMPs, and FDA standards.
• Maintain quality documentation and records management.
• Support Master Control systems and stability data management.
• Monitor stability chambers, record readings, calibrations and PM stickers.
• Prepare APR data and participate in cross-functional APR meetings.

Skills

QA experience

cGMP knowledge

document control

data reporting

MS Office

SOP adherence

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 to support the QA function for cGMP-compliant manufacturing and FDA standards. The role focuses on maintaining quality records, monitoring stability chambers, and ensuring proper change control processes are followed.

You will collaborate with Lab Ops, Product Dev, Eng, Production, QA Ops, and IT to ensure timely, accurate APR sub-reports and strict conformance to SOPs and company policies. Fluency in English is required.