Quality Assurance Specialist II (QAOTF)

The Fountain Group is currently seeking a --------Quality Assurance Specialist II for a prominent client of ours. This position is located in --Rockville,MD. Details for the position are as follows:

QA Specialist II
Location: Onsite (5 days/week, M-F)
Pay Rate: $26.50/hr
Duration: 6 Months (Potential Temp-to-Perm)

Job Description

The QA Specialist II provides Quality Assurance oversight for GMP manufacturing operations supporting cell banks, bulk drug substances, plasmid products, and final drug products. Responsibilities include batch record review, batch disposition, deviation investigations, CAPA support, change control assessment, QA floor support, and compliance monitoring.

Key responsibilities:

• Provide QA oversight for GMP manufacturing operations and client projects
• Review executed batch records, QC reports, environmental monitoring data, logbooks, and cleaning records
• Compile batch disposition documentation for product release activities
• Support deviation investigations, root cause analysis, non-conformance management, and CAPA implementation
• Evaluate and review change controls impacting manufacturing operations
• Perform QA floor activities including line clearance, room release, and real-time documentation review
• Conduct GMP audits and manufacturing walkthroughs
• Review and disposition raw materials according to approved procedures
• Issue and control batch production records and labels through QA Document Control
• Ensure SOP compliance and effectiveness through direct observation
• Review quality control testing documentation related to batch processing
• Train junior QA staff and support continuous improvement initiatives

• BS/BA in Life Sciences or a related scientific discipline

• Minimum 5 years of GMP Quality Assurance experience within biopharmaceutical, pharmaceutical, or related regulated manufacturing environments
• GMP batch record review and batch disposition experience
• Deviation management, root cause investigations, non-conformance handling, and CAPA implementation
• Change control review and quality systems support
• QA floor support, line clearance, and room release activities
• Product release documentation and raw material disposition
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• QA auditing and manufacturing compliance assessments
• Review of QC testing documentation and environmental monitoring records
• SOP compliance and document control processes
• Microsoft Excel, Word, PowerPoint, Access, and Visio

• Experience with TrackWise Digital
• Experience with Pilgrim quality management systems
• Experience supporting cell bank, plasmid, biologics, or drug product manufacturing operations