Ines Camacho
ALLENTOWN,PA
Summary
Extensive experience in the pharmaceutical industry, specializing in clinical trial packaging, Quality, Project Management, manufacturing, and compliance. Proven ability to manage all aspects of production, ensure adherence to GMPs, SOP’s, regulatory requirements, and deliver high-quality products on time and within budget—strong leadership, training, and communication skills.
Overview
22
22
years of professional experience
Work History
Assistant Project Manager
Yourway Transport Clinical
01.2023 - Current
- Develop project plans and team lists
- Maintain central files, regulatory files, and investigator site files
- Create Master Batch Records and batch records with specific variable data forms per SOP’s
- Keep training records up to date
- Create labels and label proofs for customer approvals, print labels using zebra software and zebra printers
- Proactively provide updates on project progress, including risk analyses, contingency plans, and significant changes
- Communicate project scope, timeline, goals, and sponsor input to team members
- Manage any changes to the project team throughout the project duration
- Ensure the project adheres to quality standards, SOPs, ICH-GCP, and local regulations
- Regularly update relevant management systems with accurate information
- Complete all administrative closeout procedures, including IRB termination and final milestone payments
LOT Disposition Specialist
Quva Pharma
01.2021 - 01.2023
- Reviewed and released completed batch records (includes electronic batch records) for regulatory and company SOP compliance
- Communicate promptly with operations and quality assurance regarding discrepancies
- Escalated deviations and product impacts to the Quality Investigations Team
- Analyzed variances and ensured product disposition aligned with specifications
- Entered QC testing results and generates product Certificates of Analysis (COAs)
- Performed other duties as assigned by management
- Generate KPI’s metrics reports
Documentation Control Specialist I
Accupac, Inc
01.2016 - 01.2021
- Ensured cGMP compliance in manufacturing and packaging areas
- Verified completeness and accuracy of production control records
- Reviewed and approved laboratory testing results and customer CoAs
- Managed deviation reports and issued/reviewed logbooks and notebooks
- Compiled, organized, and reviewed documentation from various departments
- Maintained paper and electronic records and performed filing and archiving
Production Coordinator
Almac Clinical Services
01.2015 - 01.2016
- Led packaging operations, ensuring quality and patient safety
- Trained and supervised production teams, monitored performance, and ensured accurate packaging
- Executed batch documents, reconciled materials, and performed inspections using COSMOS and Almac SOPs
- Managed production in cold conditions (2-8C) and oversaw thorough equipment and room cleaning
Production Specialists Coordinator
Catalent Pharma Solutions
01.2012 - 01.2015
Operational Technical Trainer
01.2009 - 01.2012
Packaging Room Leader
Fisher Clinical Services
01.2005 - 01.2009
Packaging Technician III/Quality Assurance
Fisher Clinical Services
01.2003 - 01.2005
Education
A.S. - Liberal Arts/Humanities
Lehigh Carbon Community College
Allentown, PA01.2004
Skills
- CGMP compliance
- SOPs
- Batch record management
- Quality control procedures
- Deviation management
- Training
- Supervising
- Motivating teams
- Production goals
- Attention to detail
- Accuracy
- FDA regulations
- DEA regulations
- OSHA regulations
- Clinical trials
- Warehouse Management Systems
- Laboratory Experience
- Computer Network
- ISO 9001
- Root-cause analysis
- Deadlines
- CPR
- Emergency Response
Languages
English
Spanish
Timeline
Assistant Project Manager
Yourway Transport Clinical
01.2023 - Current
LOT Disposition Specialist
Quva Pharma
01.2021 - 01.2023
Documentation Control Specialist I
Accupac, Inc
01.2016 - 01.2021
Production Coordinator
Almac Clinical Services
01.2015 - 01.2016
Production Specialists Coordinator
Catalent Pharma Solutions
01.2012 - 01.2015
Operational Technical Trainer
01.2009 - 01.2012
Packaging Room Leader
Fisher Clinical Services
01.2005 - 01.2009
Packaging Technician III/Quality Assurance
Fisher Clinical Services
01.2003 - 01.2005
A.S. - Liberal Arts/Humanities
Lehigh Carbon Community College
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