Quality assurance Documentation Lead

Clay Today; Northern (KY); Hybrid; USD 78,000 - 102,000; Full time

Job summary

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to join our Monmouth, NJ site.

You will support the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards. Under QA Mgmt you will perform day‑to‑day QA activities supporting multiple departments, maintain quality documentation, and assist with Master Control systems, including DCR PKTs, specs, test methods, stability protocols, MBRs, and MOC processes.

Qualifications

• Bachelor's degree in Chemistry, Statistics, Biology, or related field.
• At least 3 years of QA, lab, or manufacturing experience in pharma/biotech.
• Strong knowledge of cGMPs, QA documentation, and MasterControl systems.

Responsibilities

• Support QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards.
• Maintain quality documentation in compliance with company policies and records management.
• Support Master Control systems and related documentation (DCR, PKTs, specs, test methods, stability, MBRs, MOC).
• Collaborate with Lab Ops, Product Dev, Tech Svcs, Eng, Production & Packaging, QA Ops, and IT.

Skills

Quality assurance

MasterControl

MS Office

Documentation control

FDA compliance

Education

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

Job description

# Quality assurance Documentation LeadTris Pharma, Inc. Monmouth, NJ Full-time Information Services / Technology (IT)Posted on September 13, 2026Quality Assurance Documentation Lead for Tris Pharma, Inc. to work at our Monmouth, NJ loc.JOB SUMMARY: Support and assist the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards.JOB DUTIES: Under QA Mgmt, perform day-to-day operational QA activities supporting multiple depts, including Lab Ops (MV/QC/R&D-QA), Product Dev, Tech Svcs, Eng, Production & Packaging, QA Ops, and IT. Maintain 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 to ensure controlled implementation of changes. Fluency in English, written and verbal is required to meet FDA reqs. Ability to identity and distinguish colors, lift up to 30 lbs and use personal protective equipment. (A complete list of duties and benefits can be found at https://www.trispharma.com/connect/careers). May undergo background checks incl drug screening. Wage: $77,522 - $101,750 plus comprehensive benefits (A complete list of benefits can be found at https://www.trispharma.com/connect/careers).Must have Bachelor’s degree in Chemistry, Statistics, Biology, or related field and 3 yrs relevant experience with QA, lab, or manufacturing exp in the pharmaceutical or biotech industry w/ resin-based extended-release tablets/ powder/oral suspension products. Also req’s skills (3 yrs) in: current working knowledge of cGMPs in the pharmaceutical industry; maintaining Quality documentation, compliant w/ quality policies, practices, SOPs and cGMPs; quality documentation systems and control tools (MasterControl packet process and Management of Change process), incl supporting MasterControl systems on doc change requests – DCR Packet (PKT), Specifications, Test Methods, Stability Protocol, and Master Batch Records (SPTM); day-to-day operation incl issuance, archival and reconciliation of GxP physical records; MS Office; working in fast paced, matrixed, team env of internal and external team members, and (2 yrs) in: collecting and compiling relevant data for APR presentation and report summary for resin-based extended-release tablets/powder/oral suspension products and collaborating with various depts and SMEs to ensure APR sub-reports are submitted and (1 yr) in: stability chambers chart recorders, calibration and preventive maintenance (PM) stickers; notifying QA Stability Mgmt of errors or discrepancies; SLIM database to perform various research and routine tasks and assisting in daily pulling samples from stability database and stability chambers; transferring stability samples to appropriate dept; daily filing of stability change of custody records; issuing stability request forms and labels; assisting with loading new stability samples into chambers; ensuring APR schedule and timeline are followed. Apply at https://www.trispharma.com/connect/careers/.