Scientist-Chemist Resume McPherson, KS - Hire IT People

SUMMARY

Experienced in analytical/bio - analytical QC/QA production environments that comply with cGMP/GLP, OSHA, EPA, ISO & FDA regulations 21 CFR Part 11.
During last 12 years various analytical techniques being used that includes, but not limited to, HPLC
(Chemstation/Empower/Openlab), UPLC, GC, UV-Vis, FTIR, KF, Particle size (Malvern/HIAC), Dissolution, TLC, pH, Viscosity, AA spectrophometer, TOC Analyzer, ICP-MS/OES, Colorimetry, Laser Micrometer, Densitometer, Osmometer, Physical testing and data interpretations.
Familiar with the various raw materials used in several industries that include Pharmaceutical, Veterinary, Consumer products.
Assisted in OOS investigations & change control, CAPA implementation to support Quality Assurance.
Responsible for the and supervision of subordinates that involves hands on of the lab procedures, trouble -shooting instrumentation, reviewing lab analyst’s data and compliance maintenance.
Hands on experience with eLN/Biovia, LIMS/ADAGE/SAP/Master Control systems for QC/QA information.
Managed and documented scientific reporting to agencies for cGMP and ISO-9001:2008 approvals for the firm.

PROFESSIONAL EXPERIENCE

Scientist-Chemist

Confidential, McPherson, KS

Responsibilities:

Member of R&D core team focusing primarily on Customers analytical assignments.
Review Lab notebooks & Electronic notebooks along with others protocols, reports, specifications and test methods.
Routine practice of and compliance with GMP/GLP.

Shift Supervisor

Responsibilities:

Analysis: Wet Chemistry (Manual & Auto titrators), GC, UV-VIS, FTIR, pH, Density, Viscosity, Extraction
Techniques; Qualified Manual odor Tester- Raw Materials & Finished Goods, sample collection (including microbiological) from manufacturing tanks.
Managing a fluncuating volume of samples, testing, and / or data points with strict deadlines on reporting data.
Interaction and communication with plant leadership to & from P&G and ATL. Responsible for all ATL service delivery on shift.
Data management with SAP & Quality Windows tools.
SOP distribution & implementation.
Performing & Maintaining calibration and validation records for instruments and equipment. cGMP, Safety and GLP for the Lab new hires and work scheduling.

Chemist

Confidential, Overland Park, KS

Responsibilities:

Analytical & Physical testing to support Stability program, raw material & finished product release; qualitative and quantitative chemical analyses in support of new product development and registration.
Maintained lab records and related activities for FDA/CVM compliance and Audit readiness.
Addressed laboratory investigations to promote elimination of problems by identifying & addressing root cause.
Analysis: HPLC (EMPOWER 2/EMPOWER 3/Openlab), KF, Dissolution, ICP-MS/OES, & TLC Methodology, Physical testing. Methodology: USP and in-house. Variable sample volume to support R&D, production activities.
Performed validation/verification studies for test methods and cleaning verification.

QC Chemist

Confidential, Lewes, DE

Responsibilities:

Analysis: Wet chemistry techniques, HPLC (CHEMSTATION), UV-VIS, FTIR,ICP-MS, pH, Density, Viscosity, Particle size analysis (Malvern). USP, EP, and in house.
24x 7 facility with continuous samples from production throughout the shift.
Reviewed testing from other analysts in quality control.
Documented work in the lab notebook and annexures.
Discarded expired reagents and samples after the review was completed.
Conducted daily calibration check as required.
Assisted in pulling samples from stability chambers and logging samples.
Minimized waste in the lab and in the plant and promoted chemical hygiene for safe work practices.
Active member of safety committee.
Monitored inventory of laboratory reagents, Sieves log for outside calibration.