Quality Control Manager

Edgar Lozano

***** ******* ******

Reseda, California 91335

801-***-**** E-Mail: f2otb9@r.postjobfree.com

Objective

Objective is to be an asset to a corporation (Large or Start-up) that will benefit from my 18 years experience in developing Quality Systems and operation efficiencies. My overall goal is to focus on the cost effectiveness in quality systems and operation processes. I have found that large and small companies profit by achieving a balance between implementing quality systems and consistently improving efficiencies in the manufacturing process while still maintaining regulatory compliance guidelines.

Work Experience

Compliance Manager Contractor (Kaztronix)

06/2010 – Present Neutrogena (Johnson & Johnson Company)

• Currently I am part of a GMP compliance team that has been assigned to bring into compliance the R&D processes governing the manufacturing of products being submitted for safety, clinical, consumer science and home use studies. The team is also responsible in assisting in harmonizing the corporate regulatory compliance rules and regulations governing the R&D group. Writing SOPs, reviewing current practices and proposing process changes to management in order to maximize the throughput and efficiencies of the department.

Quality Manager

10/2009 – 06/2010 Paragon Laboratories ~ Torrance, California

• Responsible for creating the action plans governing compliance with 21 CFR Part 111, 114. Lead coordinator with respect to internal and external audits. Regulatory affairs functions are also my responsibility such as label review and approval, issuance of supplement fact box labels, organic certification plan implementation, issuance - review and approval of master and manufacturing batch records. My strong background in chemistry and microbiology has also been utilized supporting the laboratory functions with respect to compliance and method development protocols.

Senior Quality Manager / Operations Manager

10/2007 – 10/2009 Levlad ~ Chatsworth, California

• Responsible for creating the action plans governing compliance with 21 CFR Part 210 and 211. Levlad is third party filler for cosmetics and OTC’s and as such there are many roles I have fulfilled to support the quality unit. For example: following cGMP guidelines creating inspection procedures for packaging components and raw materials from various customers; working with product development and manufacturing to assure that packaging, labeling, and pallet configurations meet the customer’s requirements; unit of measure claims and the ability of the manufacturing equipment to match those claims have all been successfully met as part of my responsibilities. With the assistance of programmers, we have upgraded the ERP system (ORACLE) to better support the needs of manufacturing and streamline the receiving and shipping process. My background as a chemist and microbiologist is also utilized by the QC lab in cases where OOS investigations are required. I have represented LevLad during various customer and FDA audits.

Manager Quality Control Laboratory

5/2003 – 10/2007 Neways International ~ Springville, Utah

• In collaboration with the V.P. of Quality, we created and effectively implemented the quality systems governing the Quality Assurance, Quality Control, and Document Control departments. QA: Implemented an assurance process that accounts for the receiving of raw materials and components for the manufacturing of finished goods along with “in process” inspections of WIPs. QC: Designed a laboratory from the foundation up and staffed it with key asset personnel, implemented OOS, GLP, method validation, and stability protocols documenting all lab functions follow GLP guidelines. Implemented training program of lab personnel regarding UHPLC, ICP-MS and GC applications. DC: Implemented an SOP program, batch record review process, AER process, CAPA, archive retention and review process, and an auditing program all of which focus on proper GMP documentation guidelines.

Director Quality Control

5/2000 - 5/2003 Twin Labs ~ American Fork, Utah

• Direct oversight of three interdepartmental groups to assure the potency, purity and stability of the products; namely the stability, methods development, and quality laboratory. These groups collaborated to formulate products and report our findings to the regulatory, marketing, and sales teams. Responsible for the implementation of quality processes and procedures associated with daily operations of the laboratory. Implemented the “Enterprise Resource Planning” software pertaining to the quality module (SAP) and its role from QC/QA to customer orders, manufacturing, and the sale to the customer. Responsible for the throughput of raw materials and finished products based on Production Planning scheduling and Manufacturing scheduling from blending to packaging. Conducted onsite internal audits of manufacturing, regulatory, and quality units to assure their compliance with the guidelines established by SOP’s in accordance with GMP, GLP, TGA, USP and ASQ guidelines. Directly responsible for responding to onsite external audits conducted by FDA, NNFA, Shuster, as well as third party co-packers to assure compliance with GMP, OTC and International requirements.

Quality Control Laboratory Supervisor

3/1994 - 5/2000 Pharmavite Corporation ~ Silmar, California

• Quality Control Laboratory Supervisor: Supervised 22 employees, the daily running of QC laboratories, oversight of Prop 65 lead testing, as well as maintaining QC S.O.P’s current compliance with NELA/ DESHA, USP guidelines. Team leader responsible for the “Work flow laboratory cycle time reduction team” which within a year had succeeded in reducing the cycle time associated with complete testing of raw materials and finished products by fifty percent. Team leader responsible for the blueprinting and loading of the lab’s LIM system as well as overseeing its impact on the labs cycle time and performance.

• Quality Assurance Supervisor: Responsible for the supervision of eleven employees. Responsible for setting up the QA processes to meet USP and GMP guidelines as well as batch record review and approval of all raw materials used in the manufacturing process. Assure compliance with CGMP/TQM regulations. In conjunction with regulatory affairs I oversaw that DSHEA/NLEA regulations were followed.

• Stability Coordinator (QC): Responsible for the implementation of the stability program following FDA guidelines. Coordinated the tracking and trending of data with respect to chemical degradation on pharmaceutical products over time. Assigned expiration dates to finished products as data was trended and analyzed.

• Chemist, Microbiologist (QC): Responsible for the isolation and identification of pathogens in both raw materials and finished products. Conduct environmental monitoring to insure aseptic conditions are met. Prepare SOP’s in compliance with USP guidelines.

Research and Development Chemist Level II

4/1992 - 3/1994 Banner Pharmacaps ~ Chatsworth, California

• Chemist Level II (R&D): Responsible for analytical testing; using Spectrophotometric, HPLC, GC, and Dissolution methods. Under the guidance of the Master formulator; formulated new pharmaceutical products and prepared ANDA’s for formal submission to the FDA.

• Microbiologist (QC): Responsible for the isolation and identification of pathogens in both raw materials and finished products. Conducted environmental monitoring to insure aseptic conditions are met. Prepared S.O.Ps in compliance with U.S.P guidelines.

Education

Master's Degree in Environmental Occupational Health

9/1995 - 9/1997 California State University ~ Northridge California

Bachelor’s Degree in Molecular Cellular Biology and Minor in Chemistry

9/1985 - 9/1992 California State University ~ Northridge California

Skills

International Quality Auditing, Material Resource Planning Experience, Validation of Analytical Test Methods, Validation of Manufacturing Systems, SPC, Fluent in English and Spanish

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