Valarie Sandoval
Ontario,CA
Summary
Dedicated Customer Service Representative for 10 years, motivated to maintain customer satisfaction and contribute to company success. Reliable and driven, with strong time management, hardworking and prioritizing abilities. Excellent resource management and allocation skills. Outstanding communication, organizational and time management talents.
Overview
15
15
years of professional experience
Work History
Quality Assurance Specialist
Captek Pharma
05.2022 - Current
- Reviews and reconciles, production batch records (PBRs) per Standard Operating Procedures (SOPs), policies, and current Good Manufacturing Practices (cGMPs)
- Reviews the executed PBRs and supporting documentation to determine compliance with all written procedures and specifications
- Reviews GMP documents for adherence to cGMP, Good Document practices (GDP), HACCP, and Food Safety that includes but are not limited to Standard Operating Procedures, test data sheets, controlled forms, deviation records, and other GMP-related documents
- Coordinates review activities with personnel in Encapsulation, Compounding, Inspection, Packaging, Bottling, Maintenance, and QC
- Investigates discrepancies and ensures all issues are resolved
- Consolidates the PBRs and all associated supporting records into a batch file, initiates and coordinates completion of documentation pertaining to product release
- Create, review, and approve bulk and bottling case labels
- Files and maintains batch records
- Initiates NCR and deviation investigations when necessary
- Performs other duties as assigned by QA Supervisor(s) and Lead(s)
- Coordinate and perform investigations for customers and internal non-conformance issues
- Assist in preparation for customer and regulatory inspections
- Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices
- Support supplier management program
- Inventory database management, including accurate and timely updating of lot numbers and quantities
- Support regulatory/submission activities
- Ability to participate and prepare relevant materials for Management Review and Material Review Board meetings
- Perform other required duties as may be assigned
- Support clinical product manufacturing by conducting batch record review/disposition, label printing, product packaging, and shipping
- Support on-site audits conducted by customers and regulatory bodies
- Assistance with SOP creation including revisions and publication as applicable
- Maintain Quality records, reports, logs, etc
- Working knowledge of21 CFR210 and211
- Working knowledge of21 CFR110,111 and117
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
- Mentored junior QA specialists, fostering a culture of continuous learning and professional growth.
Quality Assurance Technician
Jarrow
07.2020 - 05.2022
- Perform and document a wide variety of inspections, checks, and sampling procedures during the production process
- CGMP trained
- Log in temperature and humidity into daily log and change Dickson charts
- Inspects and approves equipment, material and products at different stages of production
- Perform daily scale calibrations
- Inspects and verifies outgoing shipments for accuracy
- Release and Issue labels for Production
- Take water samples2x a month, label, log, fill out paper work and send to lab
- Perform Rodac testing on Machine and Equipment
- Perform line clearance and inspect processing area for removal of all previous product, components and foreign materials
- Perform inspection of Finished Goods
- Pull micro samples for all finished goods
- Monitor the equipment to ensure proper operation and calibration
- Monitor all aspects of the manufacturing/packaging operations and reports non-
- Perform ATP swab testing
- Perform AQL on all components
- Maintain all controlled document files and test records in a timely and accurate manner
- Enforce proper use of PPE
- Verify packaging components
- Verify bulk Labels to finished good labels
- Follow department and company SOP’s, CGMP’s and all instructions verbal and written
Quality Control Technician/Material Handler
Markwins Beauty Brand
02.2019 - 07.2020
- Receiving and Releasing Raw Materials
- Logging data into Infor
- CGMP trained
- Good Documentation Practices
- Logging data into Excel and Word Document
- Sampling Raw Materials, Labeling Raw Materials and testing Raw Materials
- Following GMP Regulations
- Following SOP’s
- Checking COA’s
- Requesting COA’s and SDS’s from vendors
- Taking DI water samples
- PH testing
- PH Calibrations
- Slip Point Testing’s
- Viscosity Testing’s
- Maintained quality documentation and records for conformance with relevant standards.
- Collaborated with production teams to address and resolve quality concerns, improving overall product reliability.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
- Performed thorough inspections of incoming materials and outgoing products.
- Enhanced product quality by conducting comprehensive inspections and identifying defects in a timely manner.
- Trained new team members on proper quality control techniques, fostering a culture of excellence within the department.
- Tested and evaluated product precision against specifications to reduce discrepancies.
Quality Control/Material Handler
Samsun Pharmaceuticals
07.2016 - 02.2019
- Raw material receiving and inspections
- Components receiving and inspections
- Calling Vendors to request COA’s and SDS’s for Raw Materials
- Work on Note One to perform logging, Labeling of raw materials and standards
- Maintained a safe work environment by following proper safety protocols and conducting regular inspections.
- Collaborated with team members to ensure timely completion of tasks and high-quality work standards.
Supervisory Specialist
ABC Warehouse
07.2010 - 01.2016
- Enhanced team productivity by implementing efficient workflow processes and optimizing resource allocation.
- Developed and executed comprehensive training programs, resulting in improved employee performance and increased retention rates.
- Evaluated employee performance objectively, providing constructive feedback and guidance for professional growth.
- Oversaw daily operations, identifying areas for process improvement and implementing strategic solutions to optimize results.
- Trained, coached and motivated staff to maintain high performance levels.
- Motivated team members through recognition of individual achievements as well as collaborative successes in pursuit of shared objectives across all functional areas involved in each project''s oversight scope.
- Kept files, logs and records updated with latest information.
- Established clear expectations and performance standards, empowering team members to excel in their roles.
- Resolved conflicts promptly through open communication and negotiation tactics, maintaining a harmonious work environment conducive to peak performance levels from each team member.
- Optimized staff scheduling and work allocation for improved productivity, reducing overtime costs and achieving more balanced workloads across the team.
Education
High School Diploma -
La Puente High School
La Puente06.2002
Skills
- Communication Skills
- Excellent communication skills and the ability to present complex information
- Problem Solving
- Excellent problem solving, critical thinking and a quick thinker
- Organized
- Highly Organized, detailed, and able to perform duties with a high degree of accuracy
- Typing
- 35 WPM
- Excel
- 5 Years Experience
- Word
- 10 Years Experience
- Detail-oriented
- Quality assurance
- Analytical thinking
- Problem-solving skills
- Decision-making
- Team collaboration
- Customer service
- Quality improvements
- Data analysis
- Quality management systems
- Team leadership
- Documentation and reporting
- Correction action planning
- Risk management
Timeline
Quality Assurance Specialist
Captek Pharma
05.2022 - Current
Quality Assurance Technician
Jarrow
07.2020 - 05.2022
Quality Control Technician/Material Handler
Markwins Beauty Brand
02.2019 - 07.2020
Quality Control/Material Handler
Samsun Pharmaceuticals
07.2016 - 02.2019
Supervisory Specialist
ABC Warehouse
07.2010 - 01.2016
High School Diploma -
La Puente High School
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