Leslie C. Reyes

***** ******** ****** Fontana CA 92336 * ady0pt@r.postjobfree.com * ady0pt@r.postjobfree.com*909-***-****

Chemist Profile

Chemistry Testing Root Cause Analysis Quality Control Supervision Staff Training Customer Service

Dynamic, accomplished and performance-driven chemistry professional determined to leverage an unmatched career maximizing operation in contributing to the bottom line.

Quality Control and Quality Assurance Expert with long track record streamlining operations, improving efficiencies, and maximizing customer satisfaction within the pharmaceutical and medical device industries.

Strong analytical and trouble-shooting abilities with proven results assessing and resolving various business/client-related issues.

Professional Experience

International Vitamin Corp (formerly Adam Nutrition), Mira Loma, CA (2004–Sept. 2017)

Dietary Supplement Contract Manufacturer.

Chemist II

Perform chemistry testing of raw materials and finished product for release.

Investigate out of specification test results. Determine root cause analysis corrective/preventative action.

Assist in method, cleaning and process validation as required.

Conduct trending of finished product and raw material test data. Create and/or initiate, review document changes (chemistry QC lab SOP’s).

Establish raw materials and finished product specifications.

Qualify suppliers and service providers.

Coordinate contract lab testing as needed.

Coordinate with the microbiology and chemistry groups for employee cross training.

cGMP training of QC and manufacturing personnel.

Guidant Corp (now Abbott), Temecula, CA (2002-Feb. 2004)

Global medical device company.

Quality Engineer

Conduct quality assurance review of lab and investigation of out of specification test results. Determine root cause analysis corrective/preventative action. Establish raw materials and finished product specifications. Qualify suppliers and service providers. Establish raw materials and finished product specifications. Qualify suppliers and service providers.

Accompanied and assisted the Corporate QA Representative during the supplier audit. Collaborated with all company laboratories and outside contract labs. Participated in and managed various special projects including cleaning validation, requirement set up for Laboratory Test Management System and evaluation of new chemicals and resin raw materials, cGMP training of QC and manufacturing personnel for the Vascular Intervention-Drug Eluting stent business group.

Leslie C. Reyes

13555 Burnside Place* Fontana CA 92336 * ady0pt@r.postjobfree.com * ady0pt@r.postjobfree.com*909-***-****

Professional Experience Continued

American Red Cross, San Bernardino, CA (1999-2001)

Blood services group, blood donor viral testing.

Lab Technician

Assist in the testing of donor blood- viral testing group.

Assist in ensuring lab is clean and in order.

Order lab supplies, ensure lab equipment are in good working condition, calibration in order. Conducted training of QC and production personnel on cGMP.

McGaw Inc. (now B. Braun), Irvine, CA (1992-1997)

Injectable drug manufacturer.

Chemistry Lab Supervisor

Supervised daily operations of the QC chemistry laboratory for one of the top Intravenous Solution Manufacturers with accountability for the analysis of raw materials, in process and finished product. Reviewed and approved chemistry testing of raw materials and finished product consistently met turnaround time release goals balancing with regulations compliance.

Designed, directed, and implemented laboratory instrument and test method validation. Upheld satisfactory level of compliance for the laboratory.

Interfaced with customers and addressed all customer inquiries. Oversaw new supplier approval. Consistently addressed deadlines for high volume raw material and finished products releases and ensured compliance to current good manufacturing practices 21 CFR parts 210,211.

Interpreted results; executed out of specification and out of trend analysis of test results and conducted pertinent investigation. Managed and assisted with special projects including new formulations transfer to production, cleaning validation and participated in LIMS expansion. Reviewed document order changes pertinent to chemistry lab operating procedures. Conducted training of lab personnel (testing, overall lab procedures, lab safety, LIMS, etc.).

Education & Credentials

Bachelor of Science Degree in Chemistry: Cum Laude Graduate Far Eastern University, Manila, Philippines

Core Competencies:

Chemistry Supervision

Quality Assurance Review

Corrective/Preventative Actions

Personnel Training

Document Changes Review

Project Management

GMP and Food Safety Practices

HPLC, GC, AA, CN Analyzer, ICPMS, FTIR, UV, etc. lab equipment skills

Test Method Verification

Internal Audits

Strong Analytical Skills

Customer Interfacing

Contact this candidate