Quality Assurance Documentation Lead

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

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. Perform daily monitoring and documentation of stability chambers, incl chart recorder readings, calibration and PM sticker checks; promptly document and notify personnel of excursions or OOT conditions. Notify QA Stability Mgmt of errors or discrepancies (missed pulls, broken/leaking samples, abnormal appearance, etc.). Utilize SLIM DB for research and routine tasks; perform daily stability sample pulls (controlled & non-controlled), transfers to appropriate depts, filing of chain-of-custody records, issuance of stability requests and labels, loading of new samples into chambers, and documentation of activities. Conduct issuance, archival, and reconciliation of GxP records, incl equipment/instrument logbooks, lab notebooks, and batch records. Ensure APR schedules and timelines are met; collect and compile data for APR reports for resin-based ER tablets, powders, and oral suspensions. Collaborate with cross-functional teams and SMEs to ensure timely, accurate, and compliant APR sub-reports; host APR risk assessment meetings and ensure attendance, document outcomes, implement and take appropriate actions on team recommendations.

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.

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).

Requirements

• 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.