QUALITY ASSURANCE SPECIALIST - Celden Consulting
(2025-01)
- Lead quality investigations, compliance assessments, and process improvement initiatives within regulated manufacturing environments.
- Analyze quality trends and operational risks to support continuous improvement and defect prevention initiatives.
- Perform root cause analysis and support implementation of corrective and preventive actions designed to improve operational effectiveness and reduce recurrence.
- Collaborate cross-functionally with operational teams to strengthen quality processes and improve compliance performance.
- Review and revise SOPs and quality documentation to support standardized and scalable operational processes.
SR. MANAGER, QA BATCH RELEASE - Emergent BioSolutions / Bora Pharmaceuticals - Baltimore, MD
(2022-10 - 2025-01)
- Led quality oversight activities supporting pharmaceutical manufacturing operations and batch disposition processes.
- Managed a team of 12 supporting batch documentation review, operational quality oversight, and regulatory compliance activities.
- Built strong partnerships with production, regulatory affairs, engineers, and Quality teams to improve process efficiency, quality consistency, and operational execution.
- Directed investigations, CAPA implementation, and root cause analysis activities to reduce quality risks and improve manufacturing performance.
- Presented quality metrics and operational performance trends during Quality Management Review meetings to support data-driven decision-making.
- Across the various manufacturing departments, I established a culture where quality was a shared responsibility with department managers and production operators demonstrating ownership and accountability.
- Responsible for implementing data driven decision-making within QMS while using trends to prioritize improvements and optional strategy.
MANAGER, DOCUMENT CONTROL & TRAINING - Emergent BioSolutions - Baltimore, MD
(2021-09 - 2022-10)
- Led Document Control and Training teams supporting enterprise quality systems and manufacturing compliance activities.
- Oversaw document lifecycle management, training compliance, and operational quality processes to maintain inspection readiness and standardized execution.
- Improved quality system processes through workflow optimization, compliance monitoring, and process standardization initiatives.
- Partnered with operational and quality stakeholders to strengthen quality culture, improve accountability, and enhance training effectiveness.
- Supported implementation of scalable quality systems supporting organizational growth and operational efficiency.
DOCUMENT CONTROL SUPERVISOR - Emergent BioSolutions - Baltimore, MD
(2019-06 - 2021-09)
- Supervised document control operations supporting manufacturing quality systems and compliance requirements.
- Managed controlled documentation processes, batch record oversight, and operational quality workflows.
- Supported continuous improvement initiatives focused on improving process efficiency, documentation accuracy, and audit readiness.
- Collaborated cross-functionally to identify process gaps and implement operational quality improvements.
- Assisted with quality metrics tracking and reporting activities to support operational decision-making.
QUALITY ASSURANCE COMPLIANCE MANAGER - Advance BioScience Laboratories - Rockville, MD
(2018-01 - 2019-06)
- Managed core Quality Managing Systems including CAPA, deviations, change control, audits, and training compliance programs.
- Conducted internal audits and compliance assessments to evaluate quality system effectiveness and operational adherence.
- Identified quality risks and implemented corrective actions to improve compliance performance and operational consistency.
- Implemented data driven decision-making within QMS while using trends to prioritize improvements and optional strategy.
- Supported continuous improvement initiatives and quality process enhancements across manufacturing and operational areas.
- Collaborated with cross-functional teams to strengthen quality culture and support sustainable compliance practices.
QUALITY ASSURANCE LEAD I - Sanofi Pasteur / Emergent (Contract, Maxis IT) - Rockville, MD
(2017-06 - 2018-01)
- Reviewed manufacturing documentation and batch records to ensure compliance with quality standards and operational procedures.
- Supported deviation investigations, CAPA implementation, and manufacturing quality oversight activities.
- Assisted with process improvements and inspection readiness initiatives.
SENIOR QUALITY ASSURANCE AUDITOR I - Ricerca Biosciences, LLC - Concord, OH
(2016-01 - 2017-06)
- Conducted internal audits and compliance assessments to evaluate quality system effectiveness and operational compliance.
- Identified process gaps, operational risks, and improvement opportunities supporting sustainable compliance initiatives.
- Delivered GMP/GDP training and compliance guidance to operational teams.
- Supported process improvement initiatives and audit remediation activities.
CHANGE CONTROL / DOCUMENT CONTROL SPECIALIST, QA - Philips Healthcare - Highland Heights, OH
(2015-01 - 2016-01)
- Supported quality systems management activities including change control, documentation oversight, and compliance reporting.
- Monitored operational quality processes and training compliance activities.
- Assisted with quality metrics reporting and continuous improvement initiatives.
Multiple Roles - Boehringer Ingelheim (BVL)
(2001-01 - 2014-12)
Supported manufacturing quality systems, operational process control, compliance oversight, training activities, and continuous improvement initiatives within FDA-regulated manufacturing environments.
- Change Control Specialist
- Batch Release Coordinator
- Batch Record Reviewer
- Document Control Specialist
- Manufacturing Specialist
