QA Documentation Lead — MasterControl & cGMP Compliance

Tris Pharma, Inc.; New Jersey; On-site; USD 78,000 - 102,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

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

The role involves Master Control, DCR PKTs, specs, test methods, stability protocols, MBRs, and change control to ensure properly implemented changes and robust documentation across departments in a fast-paced biotech setting.

Qualifications

• Bachelor's degree in Chemistry, Statistics, Biology, or related field required.
• 3+ years of QA, lab, or manufacturing experience in pharmaceutical/biotech industry preferred.
• Experience with cGMPs and FDA regulations.
• Strong documentation management and record-keeping skills.

Responsibilities

• Support QA functions to ensure compliance with SOPs, cGMPs, and FDA standards.
• Maintain quality documentation in compliance with company policies and records-mgmt requirements.
• Support Master Control systems, DCR PKTs, specs, test methods, stability protocols, MBRs, and MOC processes.

Education

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

Tools

MasterControl

SLIM database

MS Office

Job description

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

The role involves Master Control, DCR PKTs, specs, test methods, stability protocols, MBRs, and change control to ensure properly implemented changes and robust documentation across departments in a fast-paced biotech setting.