QA Documentation Lead: MasterControl & GMP Compliance

Merck & Co.; South Brunswick (NJ); On-site; USD 78,000 - 102,000; Full time

Job summary

Tris Pharma, Inc. seeks a Quality Assurance Documentation Lead to support QA compliance with SOPs, cGMPs, and FDA standards at our Monmouth, NJ site.

Under QA management, you will maintain Master Control docs, support stability programs and APR data, and collaborate with multiple departments to ensure timely, accurate records and change controls.

Fluency in English is required; background checks may be conducted. Wage: $77,522–$101,750 plus comprehensive benefits.

Qualifications

• Bachelor's degree in Chemistry, Statistics, Biology, or related field and 3+ years in QA, lab, or manufacturing.
• Strong knowledge of cGMPs, SOPs, and quality policies.
• Experience with MasterControl and GxP documentation control.
• Familiarity with APR data collection and reporting.

Responsibilities

• Maintain and reconcile quality documentation in compliance with company policies, SOPs, cGMPs, and records-mgmt requirements.
• Support Master Control systems, incl DCR PKTs, specs, test methods, Stability Protocols, MBRs (SPTM), and MOC processes.
• Perform daily monitoring and documentation of stability chambers, incl chart recorder readings, calibration and PM sticker checks; document excursions or OOT conditions.
• Collaborate with cross-functional teams to ensure APR sub-reports are accurate and on schedule.

Skills

MasterControl

SLIM DB

GxP records

MS Office

cGMPs knowledge

QA documentation

Education

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

Tools

MasterControl PKT

SPTM / Master Batch Records

Microsoft Excel

Job description

Tris Pharma, Inc. seeks a Quality Assurance Documentation Lead to support QA compliance with SOPs, cGMPs, and FDA standards at our Monmouth, NJ site.

Under QA management, you will maintain Master Control docs, support stability programs and APR data, and collaborate with multiple departments to ensure timely, accurate records and change controls.

Fluency in English is required; background checks may be conducted. Wage: $77,522–$101,750 plus comprehensive benefits.