Ruben Martinez
Diamond Bar,CA
Summary
Results-oriented professional with over 25 years of experience in quality assurance, quality control, and compliance within pharmaceutical, food, and manufacturing industries. Expertise in managing quality systems for OTC and non-OTC products, including aseptic processing, packaging, filling, and labeling. Proven ability to lead cross-functional teams, implement cGMP and regulatory standards, and drive continuous improvement initiatives. Bilingual in English and Spanish, with strong analytical, organizational, and leadership skills.
Overview
33
33
years of professional experience
1
1
Certification
Work History
Director of Quality
PL Developments / Aaron Industries Inc.
11.2014 - Current
- Overall responsibility for the Quality Assurance and Quality Control departments
- Managed internal chemical and Microbiological laboratories to perform a variety of necessary laboratory analysis to ensure the strength, identity, safety, purity, and quality of all ingredients, finished products, and packaging
- Ensure Proper quality of production processes associated with OTC products
- Reviewed and approved validation documents
- Created, reviewed, and approved Master Batch records, SOPs, manufacturing and Lab deviations, and other cGMP related documentation
- Spearheaded facility in the introduction of a pediatric electrolyte product which included the certification for Acidified foods, Kosher certification, as well as Halal certification
- Other certification included process foods registration for non-API(Active Pharmacuetical Ingrident) liquids produced which included audits performed by the California department of public health
Quality Assurance Manager
Aaron Industries Inc.
06.2009 - 11.2014
- Managed five Quality Assurance departments, including Document Control, Inventory Control Systems, Labeling, Finished Goods, and Receiving/Release components, ensuring streamlined operations and regulatory compliance
- Spearheaded the development and implementation of SOPs, driving consistency in inspections, in-process product checks, and finished goods release
- Created a weighing process that reduced costs by $1 million annually for compounding errors
- Acted as a liaison for government interactions, securing approvals for new processes and ensuring alignment with federal regulations
- Led GMP training programs, improving staff compliance with cGMP requirements and enhancing operational efficiency across departments
- Obtained Hazwoper certification and managed hazardous waste operations, mitigating environmental risks and ensuring regulatory compliance
- Reviewed and approved specifications impacting product identity, purity, and quality, ensuring adherence to stringent industry standards
Director of Quality
Constant Irwindale / Bimeda Inc.
10.2006 - 06.2009
- Led the QA/QC departments, driving adherence to corporate quality objectives and regulatory requirements for raw materials, finished goods, and stability testing
- Developed and managed departmental budgets, ensuring cost-effective operations without compromising product quality or compliance
- Conducted performance reviews, managed hiring processes, and oversaw employee training programs, fostering a culture of continuous improvement and accountability
- Executed audits of contract laboratories, raw material suppliers, and labeling vendors, ensuring compliance with cGMP standards and implementing corrective actions as needed
- Facilitated internal audits and hosted FDA inspections
Quality Engineer / Chemist
Miller Brewing Co.
10.2005 - 10.2006
- Analyzed various beer products throughout the production process, ensuring compliance with quality specifications and industry standards
- Coordinated with the Brewing department to release products based on established guidelines and specifications, improving process efficiency and product quality
- Conducted tests using advanced laboratory instrumentation, including Beer Analyzer (Scaba, Anton Paar), G.C
- (Shimadzu), and HPLC, to ensure product consistency and regulatory compliance
Quality Assurance Supervisor/Quality Control Chemist
Anthony Products Co. / Bimeda Inc.
01.1999 - 01.2005
- Managed environmental monitoring programs, ensuring compliance with environmental regulations and CGMP standards
- Directed cost-effective projects involving raw material approval, finished product analysis, and stability testing, reducing operational costs while maintaining high product quality
- Conducted investigations into deviations and non-conformance events, identifying root causes and implementing corrective actions to prevent recurrence
- Developed and implemented systems for sample tracking, raw material inspection, and in-process label control, improving product traceability and compliance with regulatory requirements
- Oversaw validation protocols and audits for compliance with corporate and regulatory standards, ensuring successful project completions and product approvals
Production Supervisor
Anthony Products Co.
01.1992 - 01.1999
- Supervised a pharmaceutical manufacturing facility with 20 employees, overseeing the production of injectables, ointments, and tablets
- Led operations in Class 100 Aseptic Filling and Class 10000 Compounding areas, ensuring strict adherence to cGMP and FDA standards
- Obtained Exemptee Pharmacist Permit (Designated Representative), facilitating compliance with state pharmacy regulations
- Directed the validation of critical equipment, systems, and processes, including aseptic filling lines, steam sterilization systems, and compressed air systems, reducing downtime and ensuring product safety
- Managed production schedules for over 30 products, ensuring timely delivery and adherence to quality standards
Education
B.S - Chemistry
California State University
Skills
- CGMP
- FDA Compliance
- USP/EP Methods
- Food Safety and Quality Program
- BRC certification
- Oracle Agile Inventory Control Systems
- Quality Control
- Process Improvement
- Aseptic Processing
- Filling
- Packaging
- Document Control
- Labeling
- Inventory Systems
- Leadership
- Team Development
- Project Management
- Labeling
- Inventory Systems
- Leadership
- Team Development
- Project Management
Certification
- FSMA certification
- HACCP validation and verification certification
- Cannery License certification
- Hazardous Waste Management, Hazwoper Certification (Incident Commander)
Timeline
Director of Quality
PL Developments / Aaron Industries Inc.
11.2014 - Current
Quality Assurance Manager
Aaron Industries Inc.
06.2009 - 11.2014
Director of Quality
Constant Irwindale / Bimeda Inc.
10.2006 - 06.2009
Quality Engineer / Chemist
Miller Brewing Co.
10.2005 - 10.2006
Quality Assurance Supervisor/Quality Control Chemist
Anthony Products Co. / Bimeda Inc.
01.1999 - 01.2005
Production Supervisor
Anthony Products Co.
01.1992 - 01.1999
B.S - Chemistry
California State University
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