Quality assurance Documentation Lead

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

Quality 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 Bachelors 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 reqs 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.