QA Specialist II

United States - Maryland - FrederickQualityRegular

Description de l'emploi

Position Summary: The QA Operations Specialist II - Continuous Improvement supports Quality Assurance Operations, operational excellence, and continuous improvement within a GMP-regulated environment. The role performs assigned support activities while applying structured problem-solving, data analysis, project coordination, and performance monitoring to improve compliance, quality, efficiency, and process reliability. The position partners with cross-functional stakeholders to identify, implement, and sustain improvements and may support additional QA Operations activities based on business needs.

Key Responsibilities:

Perform QA Operations activities to ensure compliance with GMP regulations, company procedures, site quality standards, and applicable regulatory requirements.
Review manufacturing, laboratory, environmental monitoring, and quality system documentation for accuracy, completeness, compliance, and adherence to approved procedures.
Support quality systems activities, including deviations, investigations, CAPAs, change controls, risk assessments, audits, inspection readiness, and effectiveness monitoring.
Develop, revise, and maintain controlled documents, including SOPs, work instructions, forms, training materials, and quality records.
Partner with cross-functional teams to identify compliance risks, resolve quality issues, and support timely escalation and resolution of concerns.
Support implementation of new products, processes, systems, and workflows by establishing quality requirements, controls, checkpoints, and performance metrics.
Drive and support continuous improvement initiatives utilizing Lean, Six Sigma, PDCA, A3, Value Stream Mapping, and root cause analysis methodologies.
Collect, analyze, trend, and communicate quality and operational data to identify improvement opportunities and measure effectiveness.
Develop and maintain dashboards, scorecards, project trackers, action logs, risk logs, and performance reporting tools.
Coordinate project activities including schedules, meetings, agendas, action items, risk management, and follow-up activities.
Assist with project planning and execution, including project charters, current-state assessments, future-state recommendations, implementation plans, and benefit tracking.
Support process improvement implementation and sustainment through standardization, effectiveness monitoring, and continuous evaluation.
Partner with Quality Assurance, Quality Control, Manufacturing, MSAT, Engineering, Materials Management, Site Planning, and R&D teams on quality and operational improvement initiatives.
Support inspection readiness and audit preparedness through documentation management, metric monitoring, visual management, and remediation efforts.
Prepare trend reports, quality reviews, management presentations, and training materials to support operational decision-making.
Maintain accurate, traceable, and inspection-ready records while exercising sound judgment and escalating issues when appropriate.

Basic Qualifications:

Bachelor's degree with at least 4 years of relevant experience

OR

OR an associate degree and at least 5 years of relevant experience;

OR

OR a high school diploma/equivalent and at least 6 years of relevant experience.
Onsite Monday-Friday

Preferred Qualifications:

Experience supporting continuous improvement projects in a GMP-regulated pharmaceutical, biotechnology, or cell-therapy environment.
Experience with process mapping, Value Stream Mapping, PDCA, A3, root-cause analysis, or Lean/Six Sigma tools.
Experience creating and maintaining dashboards, metrics, visual-management systems, or project-tracking tools.
Experience supporting cross-functional projects from planning through implementation and sustainment.
Lean, Six Sigma, project management, or related training/certification.
Strong analytical, technical writing, presentation, and stakeholder-coordination skills.

QA Specialist II

Description de l'emploi

Key Responsibilities:

Perform QA Operations activities to ensure compliance with GMP regulations, company procedures, site quality standards, and applicable regulatory requirements.

Review manufacturing, laboratory, environmental monitoring, and quality system documentation for accuracy, completeness, compliance, and adherence to approved procedures.

Support quality systems activities, including deviations, investigations, CAPAs, change controls, risk assessments, audits, inspection readiness, and effectiveness monitoring.

Develop, revise, and maintain controlled documents, including SOPs, work instructions, forms, training materials, and quality records.

Partner with cross-functional teams to identify compliance risks, resolve quality issues, and support timely escalation and resolution of concerns.

Support implementation of new products, processes, systems, and workflows by establishing quality requirements, controls, checkpoints, and performance metrics.

Drive and support continuous improvement initiatives utilizing Lean, Six Sigma, PDCA, A3, Value Stream Mapping, and root cause analysis methodologies.

Collect, analyze, trend, and communicate quality and operational data to identify improvement opportunities and measure effectiveness.

Develop and maintain dashboards, scorecards, project trackers, action logs, risk logs, and performance reporting tools.

Coordinate project activities including schedules, meetings, agendas, action items, risk management, and follow-up activities.

Assist with project planning and execution, including project charters, current-state assessments, future-state recommendations, implementation plans, and benefit tracking.

Support process improvement implementation and sustainment through standardization, effectiveness monitoring, and continuous evaluation.

Partner with Quality Assurance, Quality Control, Manufacturing, MSAT, Engineering, Materials Management, Site Planning, and R&D teams on quality and operational improvement initiatives.

Support inspection readiness and audit preparedness through documentation management, metric monitoring, visual management, and remediation efforts.

Prepare trend reports, quality reviews, management presentations, and training materials to support operational decision-making.

Maintain accurate, traceable, and inspection-ready records while exercising sound judgment and escalating issues when appropriate.

Basic Qualifications:

Bachelor's degree with at least 4 years of relevant experience

OR

OR an associate degree and at least 5 years of relevant experience;

OR

OR a high school diploma/equivalent and at least 6 years of relevant experience.

Onsite Monday-Friday

Preferred Qualifications:

Experience supporting continuous improvement projects in a GMP-regulated pharmaceutical, biotechnology, or cell-therapy environment.

Experience with process mapping, Value Stream Mapping, PDCA, A3, root-cause analysis, or Lean/Six Sigma tools.

Experience creating and maintaining dashboards, metrics, visual-management systems, or project-tracking tools.

Experience supporting cross-functional projects from planning through implementation and sustainment.

Lean, Six Sigma, project management, or related training/certification.

Strong analytical, technical writing, presentation, and stakeholder-coordination skills.