VALERIE ALAMEDA
Needville,TX
Summary
Dynamic quality professional with extensive experience in the manufacturing, cosmetic, and skincare industries. Proven track record in establishing and maintaining quality management systems compliant with ISO 22716 and cGMP standards. Expertise in fostering collaboration with international and U.S. vendors, as well as cross-functional teams, to uphold product quality and ensure regulatory compliance. Committed to driving continuous improvement and operational excellence in fast-paced environments.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Sr. Director of Quality
Ledge Loungers
2024.10 - Current
- Developed and implemented quality management systems to streamline processes and improve operational efficiency.
- Mentored staff on best practices in quality control, fostering a culture of excellence and accountability.
- Oversaw corrective action plans, ensuring timely resolution of non-conformance issues within production processes.
- Built strong partnerships with key stakeholders, enabling increased collaboration on problem-solving efforts and overall process improvements.
- Collaborated with suppliers to enhance their understanding of our quality requirements, fostering strong relationships built on trust and transparency.
- Reviewed technical documentation for accuracy and completeness, reducing potential errors in product specifications or assembly instructions.
- Drove root cause analysis investigations for customer complaints, implementing corrective actions that reduced recurrence rates and improved client retention.
- Conducted regular supplier audits to assess compliance with quality standards and identify areas for improvement.
- Collaborated with cross-functional teams to drive continuous improvement in product quality and customer satisfaction.
- Analyzed data trends to inform strategic decision-making in quality enhancement initiatives.
- Collaborated with cross-functional teams for effective problem-solving during product development stages.
Director of Quality
Luminess Direct
2013.09 - Current
- Initiated, developed, and maintained a Quality Management System (QMS) to ensure compliance with government regulatory standards and agency guidelines. Successfully executed and led 2 certification audits and 6 surveillance audits with the ISO 22716 registrar, achieving a 100% success rate and no major findings.
- Established and worked with internal audit team, identified improvement to enhance efficiency and reduce manufacturing costs, while securing annual ISO 22716 certification and adhering to regulatory standards. Addressed CAPA and Nonconforming events by investigating root cause and resolving in a timely manner.
- Facilitated all third-party inspections for international and U.S. suppliers by collaborating with product development, R&D, and marketing to establish testing protocols, product specifications, packaging, and labeling, min/max requirements, key release criteria, and other functional or visual criteria.
- Established and maintained quality standards, overseeing 70+ domestic and overseas manufacturers for finished goods, packaging, and raw materials. Led efforts with cross functional team to incorporate quality considerations, review of packaging, labels, and marketing claims to ensure regulatory compliance.
- Supported the establishment and design of a 15,000 sq ft manufacturing facility, overseeing adherence to cGMP and ISO standards to ensure compliance with regulatory requirements and operational efficiency.
- Designated as the dedicated individual to oversee FDA establishment registration and product listings annually. Led and managed FDA audits to ensure compliance.
- Oversaw and managed all aspects of testing, both internally and with external laboratories. Developed and approved stability protocols to ensure product quality and compliance with industry standards.
- Oversaw Quality and R&D lab including management of supplies, calibration of equipment, color matching and formula reviews.
- Worked with the Customer Service to review customer complaints, identify areas for improvement, and implement effective solutions. Streamlined complaint data collection, allowing quality team to identify trends and capture key information, resulting in a 50% reduction in investigation time for complaints.
- Created, maintained, and updated troubleshooting criteria in CRM system, improving customer service agents' ability to resolve quality issues effectively. Trained customer service on product knowledge, usage, and troubleshooting.
- Performed new hire and ongoing employee training - cGMP, hygiene, SOP's, STM's and company policy.
- Leading to a 20% decrease in call volume and a 10% reduction in WRN shipments.
Director of Quality and Production
Luminess Direct
2018.05 - 2022.01
- Implemented quality control measures to maintain high standards of service delivery. Oversaw daily operations, ensuring tasks and projects were completed while strictly adhering to a zero-overtime policy.
- Negotiated contracts with vendors and suppliers to secure favorable terms for organization resulting in a 20% decrease in testing cost annually. Drove cost-reduction through waste-minimizing practices, strong inventory control and meticulous vendor selection.
- Collaborated with a Senior Engineer to create a preventive maintenance schedule and spare parts inventory, reducing equipment downtime by 30%. Reviewed and updated batch records to define clear formulation criteria, resulting in a 30% decrease in compounding errors and non-conforming batches.
- Conducted project meetings with internal team members and cross functional team to discuss issues or concerns. Monitored inventory levels to prevent stockouts or excessive holding costs and improving company operations.
- Fostered positive work environment by addressing employee concerns promptly, decreasing turnover to 10% quarterly. Hired, and guided employees through empowered training and motivational strategies, evaluated staff performance and conducted annual performance reviews. Oversaw the implementation of employee self-service payroll and HR software.
- Responsible for facility maintenance activities to ensure facility was operating safely and efficiently
Product Quality Manager
Luminess Direct
2011.12 - 2013.09
- Established all quality-related processes and controls for internal and external stakeholders such as key retailers to implement a defined quality program. Developed and executed testing protocols for incoming products and materials.
- Generated and maintained comprehensive documentation of all testing results, inspections, and process improvements. Collaborated with the supply chain team to improve and integrate processes for new and existing products.
- Implemented an inbound inspection program with a sampling plan and established Acceptable Quality Levels (AQLs) for products.
- Provided critical thinking from quality perspective to R&D for formula development, skincare device sourcing and launching of new products and brands.
- Reported monthly on trends, improvements and needs of quality department. Worked with the management team to address and resolve complaints and quality concerns.
Distributor Support Specialist
Luminess Direct- Stream Cosmetics
2009.10 - 2011.12
- Managed distributor accounts, including bulk order placements, order status tracking, and resolution of back-office issues. Oversaw the CRM system to ensure smooth operations.
- Collaborated with marketing and event specialists to plan and host recruitment and training events. Led weekly online training sessions for new distributors and staff on back office operations, the compensation plan, products, and services.
- Compiled data to create sales reports and commission summaries for upper management.
Education
High School -
Needville High School
Needville, TXSkills
- Supplier Quality Management
- SOP Development
- Product Inspection
- Quality Management Systems
- ISO 22716/ 21CFR 210 & 211
- Regulatory Requirements
- Audit Preparation
- Supply Chain
- CGMP
- Collaborate Cross-Functionally
- Process Improvements
- Stability Programs
Certification
- ISO 22716 cGMP certification
- SGS
Timeline
Sr. Director of Quality
Ledge Loungers
2024.10 - Current
Director of Quality and Production
Luminess Direct
2018.05 - 2022.01
Director of Quality
Luminess Direct
2013.09 - Current
Product Quality Manager
Luminess Direct
2011.12 - 2013.09
Distributor Support Specialist
Luminess Direct- Stream Cosmetics
2009.10 - 2011.12
High School -
Needville High School