Pharmaceutical Professional

SUMMARY OF QUALIFICATIONS

Laboratory Management professional with proven success leading team to meet aggressive Quality Control laboratory goals. Recognized for ability to plan, design, and implement change in a dynamic environment. Experienced in GMPs/GLPs, compendia methods, FDA requirements, lab investigations, change control, lab auditing, and monitoring of lab training activities. Exerted positive influence through coaching and mentoring. Provided technical guidance in reviewing analytical methodology, ensuring compliance with GMPs, and implementing QC laboratory process improvements.

PROFESSIONAL EXPERIENCE

WATSON LABORATORIES, INC., Copiague, NY 2004 – 2010

Supervisor Lab Operations: Maintained lab scheduling for testing of finished product, in-process, raw material, and stability samples. Assisted in maintenance of departmental budget. Proved ongoing efficacy, safety and purity of commercial products, and raw materials through testing as per USP/EP/ICH.

-Raised productivity and quality output, while reducing errors, through improved communication, team building, creative strategies and continuous improvements. Revised analytical methods to enhance operational efficiency.

-Passed all internal audits and external agency (e.g. FDA, EU, MHRA, EPA) inspections. Provided inspection readiness training. Reinforced best industry practices, corrective/preventive actions (CAPA), and GMP/GLP compliance during status meetings. Established alert limits and monitored QC metrics.

-Developed, challenged and motivated staff to excel and earn career advancement. Effectively coached and counseled staff to resolve unsatisfactory performance and conduct issues. Issued warnings/corrective actions and performance improvement plans (PIP). Harmonized performance review document template by aligning key responsibilities with core values. Selected key personnel during hiring process laying foundation for process excellence.

-As site project lead, wrote lab investigation SOP and harmonized tracking system to meet major corporate goal. Conducted User Acceptance Testing (UAT) and trained users on system and SOP upgrades. Received honors and praise for team accomplishments.

-Successfully monitored lab investigations, and deviations. Wrote or reviewed lab investigation reports (LIR) for out-of-specification (OOS), out-of-trend (OOT) and aberrant results. Employed effective troubleshooting skills to quickly determine root cause. Established appropriate CAPA response. Implemented improvements by CAPA deadline.

-Managed lab training program ensuring 100% compliance. Increased staff competency and flexibility through cross-training. Coordinated SOP and structured on the job training (SOJT) activities. Established SOP risk assessments while supporting restructuring of curricula.

WATSON LABORATORIES, INC., Copiague, NY 2002 – 2004

Sr. Chemist: Tested solid dosage, raw materials and cleaning agent samples as per USP/ ICH guidelines to support investigations, process validation, vendor qualification, method development, and method validation. Led method transfer and training activities. Assessed stability over product life cycle. Profiled impurities and degradation products. Tested peak purity of drug substances, products, placebos, and cleaning agents. Wrote or reviewed method validation and protocols/reports/studies.

-Developed, validated and transferred lab test methods for cleaning agents used in manufacturing. Selected as subject matter expert (SME) for cleaning agent test methods.

-Managed laboratory waste disposal process ensuring successful EPA inspections.

-Performed method verification in response to compendia changes to ensure current and accurate analytical methodology.

WATSON LABORATORIES, INC., Copiague, NY 1999 – 2002

QC Chemist: Supported production plan through testing of finished goods, in-process, stability and raw material samples as per USP and in-house methods.

-Consistently met and exceeded quality and production plan objectives.

-Selected as SME for finished product testing. Led training and troubleshooting activities assuring continuous improvement of QC functions.

-Provided accurate and timely submission of experimental test results for manufacturing deviations, product deficiencies and customer complaints.

SUFFOLK COUNTY WATER AUTHORITY, Hauppauge, NY 1998 – 1999

Chemist: Performed tests and experiments on water, soil and air samples using complex methods and instrumentation.

-Passed all proficiency tests to satisfy federal, state and local agency standards.

NYTEST ENVIRONMENTAL, INC., Port Washington, NY 1995 – 1998

Auditor: Conducted internal audits of lab practices. Reviewed lab test reports for accuracy and completeness. Involved with agency inspections and monitoring of lab practices.

-Reinforced best lab practices assuring successful audits.

-Supported management goals and lab staff while passing all proficiency test requirements.

TECHNICAL & COMPUTER PROFICIENCY

Proficient using GC, GC/MS, and HPLC instrumentation. Employed FT-IR, UV/VIS, TLC, Karl Fischer titration, and wet chemistry techniques. Strong knowledge of Empower CDMS, Labware LIMS, Trackwise, Livelink, ISOTrain, JDE and Microsoft Office (Word, Excel, Power Point).

EDUCATION & TRAINING

Master of Science Degree with distinction – Environmental Technology

Thesis: Bioremediation of PCBs in Anaerobic and Aerobic Sediments

New York Institute of Technology, Old Westbury, New York

Bachelor of Science Degree – Biological Sciences

State University of New York at Stony Brook

Comp Tia A+ / Comp Tia Network + Computer Certification

Briarcliffe College: Bethpage, New York

Fundamentals of Project Management, Critical Path Management Resources, Inc.

Managing and Eliminating Unacceptable Behavior and Other Employee Performance

Barriers, Skill Path® Seminars

Practical Method Development & Validation for HPLC, Waters Connections University

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