Action-oriented Scientist in search of a Quality Management position in the Medical Device /

Pharmaceutical / Petrochemical industry

Summary of Qualifications

30+ years experience in QA / QC, Research / Development and Operations

Lead /Team Member on Executive Steering Committee, Material, Product, Documentation, Testing Methods, Validation, Research, and Product Support Review Board

Project & Validation Lead, on Testing Method Development, Optimization of Test Method / Equipment / Production processes, & Continuous Improvements

Consultant / Adviser to Customer / Technical Service, Regulatory Compliance, QC, R&D & Production processes

Quality assurance area of responsibility – documentation, complaints, customer interaction, product commercialization

Material Review Board Coordinator, in-charge of identifying / final disposition of Deficient Materials

Knowledgeable in CFR 21 part III (FDA) and FALCPA (Allergens)

Lead/Team Member in hiring, training and mentoring of Scientists and Senior Scientists

Subject matter expert on raw materials, products, test methodologies and regulatory compliance documentation

Analysis of incoming raw materials, in-process and products for release

Six Sigma Greenbelt Trained

Employment / Work History

Glanbia Nutritionals / Carlsbad, CA

QA Associate, March 2014 – August 2015 (Full Time)

In- charge of customer complaints / investigating & resolving technical issues, commercialization of new formulated blends for customer & new raw materials. Supports and assist in quality documentation and servicing customer service in customer requirements & inquiries. In-charge of ingredient substitution in blends / evaluating materials that can be approved in blend products. Creating SOPs, initiating, evaluating and completing cleaning, blender, product validations and testing methods.

Highlights: Resolved technical complaints with customers, technical issues in production and completion of validation processes.

QC Material Review Board Coordinator, July 2013 – March 2014 (Contract)

In-charge of deficient materials – investigates non conforming / deficient raw materials, finished goods .Gathers information on and inspects deficient materials including documenting, reviewing, physical inspection of packaging and material, physical appearance, color, sample testing specifications as required. Presents findings and completes documentation with resolution to management. Familiarity with Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), and CFR 21 Part III, concerning allergens statements and cGMP in the food and drug industry.

Highlights: Reduced material deficiencies from 2M to 50K.

Becton Dickinson / Hunt Valley, MD

Product Support Sr. Scientist, 2010 – February 2013 (retired)

Product Support Supervisor, 2005 – 2010

Researched, proposed and done feasibility studies on technical instrumentation. Have been involved with installation and start-up of analytical instrumentation such as UV-Vis., HPLC, HPIC, UPLC, AA/AE, ICP-OES, GC-MS, FT-IR, Microwave Digestion System and other lab instruments.

Responsible and in-charge of validation studies per ICH (International Commercialization and Harmonization), from conception to fruition. Statistical tools such as Six Sigma are employed.

Highlights: Satisfactory completion of Test Method and Process Validations according to the Validation Master Schedule. Annual Cost Savings of 250K+ in troubleshooting production issues.

Media Process Technology Group / QC – Group Leader, 2001 – 2005

Sr. Analytical Chemist, 1999 – 2001

Subject Matter Expert on Dehydrated Culture Media, Liquid Media, Plated Media & Raw Materials. Provide technical, chemical support and consultation to Associates, Manufacturing, QA / QC, Research and Development, Vendors, External Customers, Audits (both internal, customer and governmental), Technical / Customer Service concerning product analysis and testing methodologies. Lead investigator for testing, manufacturing and processing issues pertaining to raw materials, in-process and final products. Provide testing, determining root cause and resolution.

Highlights: Yearly cost savings in material and production rework / salvages of $250K+. Successful integration of BD & Difco Chemistry group, and establishing various work centers.

Difco Laboratories / Becton Dickinson, Detroit, MI

R&D Chemist, 1992 – 1999

QC Chemist III, 1990 - 1992

QC Chemist II, 1981 - 1990

QC Chemist I, 1978 – 1981

Responsible for chemical analysis and disposition of incoming raw materials, in-process manufactured products, preliminary, final and stability products. Product analysis involves organic and inorganic chemical testing, dehydrated culture media evaluations, antibiotics and some microbiological assays. Involved in writing technical reports, maintaining quality records and ensuring lab is in line per ISO, cGMP and FDA regulations., was responsible for timely analysis, review, approval and release of raw materials and products.

Highlights: Established SOP’s for the Chemistry Group, and satisfactory completion of Test Method Validations. Initiated troubleshooting support with Operations.

Work Skills

Technical Skills: Well versed in leading, writing, amending, validating per validation toolkit and ICH, training personnel and implementing procedures per GMP, FDA and ISO which include testing methodologies, in-process and final product transfer to other departments / facilities, analytical instruments in the technical lab. As a Group Leader / Supervisor have mentored in developing, reviewed and released validated procedures.

Communication Skills: Interacted fully with staff, management, and other departments in Chemistry Team, Material Review, Research/Development and Executive Steering Committee Meetings to ensure that analysis of materials and products, method and instrument validations, documentations including batch reviews, CAPA’s, OOS’s and test requests, product support and projects are completed within an agreed given time frame, communication with internal and external customers are maintained ensuring smooth continuity and harmony in the business.

Miscellaneous: Experienced in the use of personal computers, whether linked to analytical instruments or stand-alone. Developed programs for lab use either to be used in operating a particular equipment or for major calculations involving macros, linear regression, etc. Proficient in the use of Microsoft Word, Excel, Powerpoint, MS Project, Visio, Minitab, Lotus Notes, Outlook, SAP and QDMS. Six Sigma Greenbelt trained.

Education

B.S. Chemistry, 1976 - Far Eastern University, Manila, Philippines

Seminars / Workshops Attended

BD Seminars / Workshops – Management training, SAP, ISO, ICH, Selecting the Best Practices, GMP, Six Sigma Green Belt training, Safety & STOP training, SOP Procedures, Project Management, Validation Associate training, Lean Manufacturing.

Technical training on various Analytical Instrumentation.

Project Management Workshop

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