Ines Camacho
Allentown,PA
Summary
26 years of pharmaceutical experience in clinical trials including secondary, primary packaging, commercial cosmetics packaging and manufacturing. Experienced in all functions associated with packaging of clinical trial supplies and assured compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations. Experience with electronic batch record review and finished goods ensuring they are all in compliance with cGMP and SOPs. Create Master Batch Records, Review and release of completed Batch Records. Extensive knowledge with Master Control, KPIs, spreadsheets and databases for quality and production departments as well as with document control functions. Experience with coordination of department assignments; cover multiple look-alike blister card packaging, over-encapsulation, bottle filling, pouching operations, clinical labeling. Batch Record creation, review, and release of finished good materials.
Overview
12
12
years of professional experience
Work History
LOT DISPOSITION SPECIALIST
QUVA PHARMA
01.2021 - Current
- Reviews and releases completed hard copy and electronic Batch Records for compliance with proper GDPs and QuVA Pharma SOPs
- Ensures product quality and safety standards are met
- Responsible for reviewing bulk products and finished good Lots
- Review pick lists to ensure Lot Numbers, Items match job headers
- Review expiration dates
- Reviews Variances associated with batch records for impact to the product disposition
- Reviews QC testing results, and environment monitoring data, are within specifications
- Enters QC testing results into Management System to generate product Certificate of Analysis (COA)
- Promptly communicates with Operations and Manufacturing Quality Assurance regarding batch record discrepancies, product issues/variances
- Escalates procedural deviations or discrepancies that have product impact to the Quality Investigations Team for review
- Use LMS system for verification of lab results and to generate C of Cs
- Use INFOR system to release and relocate lots for disposition
- Other duties as designated by Supervision.
DOCUMENTATION CONTROL SPECIALIST I
ACCUPAC, INC-MAINLAND
01.2016 - Current
- Ensure compliance with cGMP standards in the Manufacturing and Packaging areas
- All production control records have been compiled and are complete and accurate
- All Laboratory Services release testing showed satisfactory conformance to bulk and finished product specifications
- Execute or coordinate the resolution to excursions identified during the batch review process
- Review and approve micro lab and Analytical lab testing results
- Approve CoA as customers disposition requirements
- Upload CoA into SharePoint
- Approve testing results in LIMS (Laboratory Information Management System) Review and approve deviations report per customer and company requirements
- Issue and perform reviews of logbooks and notebooks
- Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories
- Adherence to customer release requirements
- Update paper and electronic records
- File and archive documentation.
PRODUCTION COORDINATOR
ALMAC CLINICAL SERVICES
Souderton
01.2015 - Current
- Performs and inspects operations relevant to the packaging area ensuring that quality is maintained in products for the safety, well-being, and protection of the patient
- Accept and perform a leadership role while in packaging rooms, including training the production team on the packaging operation and monitoring the performance of the staff to ensure the finished product is being packaged correctly
- Execute batch documents including issuance, reconciliation, recording of the finished product, and required inspections using the COSMOS system and manually recording details needed in the batch document according to appropriate Almac Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP's)
- Must be able to perform Production Coordinator functions to Package/Assemble/Label material as detailed in the batch document within cold conditions (2-8C) as required by individual operations
- Perform and ensure that thorough, routine cleaning of equipment and packaging rooms is performed according to appropriate (Almac SOP's) and current Good Manufacturing Practices (cGMP's).
CLINICAL PRODUCTION COORDINATOR
Catalent Pharma Solutions
Philadelphia
01.2013 - Current
- Assigned to and responsible for the overall execution, training, monitoring, and supervising clinical production staff within a specific clinical packaging batch record operation
- Responsible for safety, quality, production rates, material reconciliation, and timelines adherence in the specific Production Batch Record operation assigned
- General knowledge of clinical applications regarding randomization schedules, open-label, blind labeling, study collation and treatment groups
- Monitors, organizes, and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations in the specific Production Batch Record assigned to
- Oversees specific batch record operations assigned to which includes both primary and secondary production rooms equipped with various pharmaceutical packaging equipment including but not limited to automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing
- Responsible for maintaining and ordering personnel safety disposable and supporting packaging supplies for specific assigned production room operation
- Responsible for entering data accurately in batch records and logbooks
- Review completed manufacturing and packaging batch records in a prompt time.
OPERATIONS TECHNICAL TRAINER
Fisher Clinical Services
Allentown
01.2012 - Current
- Support the Operations group by providing on-the-job training to packaging personnel of various levels (Tech I through Team Leader)
- Provide regulatory training to Operations personnel to stay in compliance with regulatory agencies
- Perform job shadowing and performance observations to packaging employees who are undergoing training for various job tasks to meet performance expectations
- Assist Operations Support staff with creating, implementing and delivering of training programs
- Assist Technical Trainers with the creation of training programs designed to assist personnel within Operations to understand customer requirements, technical requirements and Standard Operating Procedures (SOPs)
- Assist in performing and leading teams and projects related to improving processes in operations such as FMEAs and/or PPI
- Write investigation and deviation reports for clients using Track Wise system
- Worked at Fisher Clinical Services from 2000 to 2013 in various job positions
- (Quality Assurance, Packaging Line Leader, Production Group Leader)
Education
A.S. in Liberal Arts/Humanities -
LEHIGH CARBON COMMUNITY COLLEGE ALLENTOWN
01.2004
Skills
- Pharmaceutical Packaging
- Operations
- Product Quality (QA/QC)
- Spreadsheets
- Leadership
- Cosmetics
- Clinical Trials
- Quality Assurance
- Information Management
- Reconciliation
- Safety Standards
- Management
- Numbers (Spreadsheet)
- Investigation
- Electronic Batch Records
- Master Control
- Warehouse Management Systems
- Cardiopulmonary Resuscitation (CPR)
- Warehouse Management
- On-The-Job Training
- Seal (Mechanical)
- Management Systems
Languages
English
Languages
Spanish
Native/ Bilingual
Timeline
LOT DISPOSITION SPECIALIST
QUVA PHARMA
01.2021 - Current
DOCUMENTATION CONTROL SPECIALIST I
ACCUPAC, INC-MAINLAND
01.2016 - Current
PRODUCTION COORDINATOR
ALMAC CLINICAL SERVICES
01.2015 - Current
CLINICAL PRODUCTION COORDINATOR
Catalent Pharma Solutions
01.2013 - Current
OPERATIONS TECHNICAL TRAINER
Fisher Clinical Services
01.2012 - Current
A.S. in Liberal Arts/Humanities -
LEHIGH CARBON COMMUNITY COLLEGE ALLENTOWN
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