Quality Assurance Documentation Lead

Job Summary

Support and assist the QA function to ensure manufacturing quality controls and procedures comply with SOPs, cGMPs, and FDA standards.

Responsibilities

• Under QA Management, perform day-to-day operational QA activities supporting multiple departments, including Lab Ops (MV/QC/R&D-QA), Product Dev, Tech Svcs, Engineering, Production & Packaging, QA Ops, and IT.
• Maintain quality documentation in compliance with company policies, SOPs, cGMPs, and records-management requirements.
• Support Master Control systems, including 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, including chart recorder readings, calibration and PM sticker checks; promptly document and notify personnel of excursions or OOT conditions.
• Notify QA Stability Management 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 departments, 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, including 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.

Qualifications

• Bachelor's degree in Chemistry, Statistics, Biology, or related field.
• 3 years relevant experience with QA, lab, or manufacturing experience in the pharmaceutical or biotech industry with resin-based extended-release tablets/powder/oral suspension products.

Required Skills

• 3 years of experience with:
  • Current working knowledge of cGMPs in the pharmaceutical industry.
  • Maintaining Quality documentation, compliant with quality policies, practices, SOPs and cGMPs.
  • Quality documentation systems and control tools (MasterControl packet process and Management of Change process), including supporting MasterControl systems on document change requests – DCR Packet (PKT), Specifications, Test Methods, Stability Protocol, and Master Batch Records (SPTM).
  • Day-to-day operation including issuance, archival and reconciliation of GxP physical records.
  • MS Office.
  • Working in fast-paced, matrixed, team environment of internal and external team members.
• 2 years of experience with:
  • Collecting and compiling relevant data for APR presentation and report summary for resin-based extended-release tablets/powder/oral suspension products.
  • Collaborating with various departments and SMEs to ensure APR sub-reports are submitted.
• 1 year of experience with:
  • Stability chambers chart recorders, calibration and preventive maintenance (PM) stickers.
  • Notifying QA Stability Management 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 department.
  • 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.

Additional Requirements

• Fluency in English, written and verbal, required to meet FDA requirements.
• Ability to identify and distinguish colors.
• Ability to lift up to 30 lbs and use personal protective equipment.
• May undergo background checks including drug screening.

Pay & Benefits

• Wage: $77,522 - $101,750
• Comprehensive benefits (complete list available at https://www.trispharma.com/connect/careers)