QA Documentation Lead: Pharma Compliance & Records

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

Job summary

Tris Pharma, Inc. in Monmouth, NJ seeks a Quality Assurance Documentation Lead to support QA across departments and ensure compliance with SOPs, cGMPs, and FDA standards.

You will maintain quality documentation, assist with MasterControl systems, and help manage stability data, change control, and batch records while coordinating with SMEs. Excellent English communication and attention to detail are required.

Qualifications

• Bachelor's degree in a science field and 3+ years in QA, lab, or manufacturing in pharma/biotech.
• Strong knowledge of cGMPs and FDA requirements, and document control practices.
• Experience with MasterControl, change control, and GMP records management.

Responsibilities

• Support QA daily operations across multiple departments and ensure policy compliance.
• Maintain quality documentation and records in accordance with SOPs and cGMPs.
• Support MasterControl systems, change controls, specs, stability, and batch records.
• Monitor stability chambers, perform calibration checks, and document excursions.
• Prepare APR data and assist with cross-functional APR risk assessments.

Skills

Quality Assurance

Documentation control

cGMP knowledge

MS Office

Education

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

Tools

MasterControl

SLIM DB

MS Office

Job description

Tris Pharma, Inc. in Monmouth, NJ seeks a Quality Assurance Documentation Lead to support QA across departments and ensure compliance with SOPs, cGMPs, and FDA standards.

You will maintain quality documentation, assist with MasterControl systems, and help manage stability data, change control, and batch records while coordinating with SMEs. Excellent English communication and attention to detail are required.