Oluwasegun Akerele

**** ** **** ****, ***********, FL 32608, United States. Mobile: +1-516-***-****. Email: adxtcn@r.postjobfree.com

WORK EXPERIENCES

EDGEWELL PERSONAL CARE Ormond Beach, FL, USA

**/*023 – present Technical Writer

Responsible for investigating, preparing, reporting and documentation of laboratory deviations, out of specification investigations, microbial non conformances and complaints that are reported

Lead and write quality investigations such as deviations/CAPAs/Quality Protocols

Developed or maintain templates for documents

Developing, writing, releasing, and publishing technical reports, work instructions and correspondence, in accordance with standard operating procedures

completes the investigations and closure of the incidents/CAPAs within the time frame

Assist QC management and perform other documentation work as required for change controls, SOPs, specifications, protocols etc

Gather information from all necessary internal and external sources to find the root cause and to evaluate the impact of the deviation/investigation on drug substance or drug product, as well as the risk.

Properly assess the analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate

APPLIED GENETIC TECHNOLOGIES CORPORATION Alachua, FL, USA

10/2021 – 12/2022 QA SPECIALIST (Contractor)

Independently performs technical review of data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots.

Signs off analytical data forms on laboratory information management systems (LIMs) for product release.

Ensures Completion of Periodic/Biennial Review of GMP documents.

Supports investigations of OOS/OOT, deviations, CAPAs, Change Controls, and Planned Variances that occur within the QC laboratory.

Review results of deviations/ investigations from Contract Testing Laboratories (CTLs) as well as our in-house microbiology group.

Created and revised QC Standard Operating Procedures, Test Records, Stability and Assay Qualification Protocols and Reports to ensure compliance with the requirements of the QC Analytical laboratory and various regulatory agencies.

Ensured Completion of Periodic/Biennial Review of GMP documents.

As needed, reviewed results of deviations/ investigations from Contract Testing Laboratories (CTLs) as well as our in-house microbiology group.

Supports Out-Source Team to manage sample data on LIMs

CONTRACT PHARMACAL CORPORATION Long Island, NY, USA

05/2020 – 08/2021 QC CHEMIST

Operated general analytical instruments for all routine testing (i.e., HPLC, GC, ICP-MS, UV, Karl Fischer and FT-IR).

Performed solvent extraction and acid digestion for ICP-MS analysis.

Performed wet chemistry tests (i.e., LOD, pH, ROI, titration, etc.).

Complied with good housekeeping and safety practices; ensures the collection and proper disposal of hazardous waste from laboratory instruments.

Participated in troubleshooting of analytical test methods and laboratory instruments.

Assisted with laboratory investigations of OOS and Deviations

Performed testing of in-coming raw and packaging materials in accordance with USP compendia.

Proficient in various UPLC and HPLC software programs, such as Empower 2 and Chromeleon 6.8

Perrigo Company plc Leeds, United Kingdom

03/2016 – 12/2019 QC ANALYST 2

Investigating out of spec (OOS) and out of trend (OOT) results using root cause analysis.

Troubleshooting and providing routine maintenance for a range of analytical equipment like Analytical balance, HPLC, Density meter, pH meter and the likes.

Spearheading daily team meeting for analytical reports and updates.

Checking analytical documents and results for errors, omissions and deviations using GMP approach.

Carried out product identification test using TLC technique, solvent extractions in accordance with standard compendia.

Calibration and operation of Karl Fisher to Determining products moisture content.

Measurement of products specifications using HPLC (with Chromeleon version 6.8 and 7.2), FTIR, PH-meter, Disintegration apparatus in accordance with international standard.

Updated logs and records consistently to facilitating comprehensive information for review and audits.

Analysed finished and stability samples in accordance with standard operating procedures and methods by carefully observing Right First Time (RFT) principles.

Undertook routine analysis of raw materials, in-process samples, final APIs and stability samples using correct and proper protocols outlined by Standard Analytical Methods (SAM’s), SOP's and Compendia references.

Generation of record of analysis and certificate of analysis for all in-process samples and finished products respectively.

Trained and developed new QC analyst into high-performing team members.

Other roles given by Manager as the business demands.

GLAXOSMITHKLINE Plc Lagos, Nigeria

02/2013 – 12/2015 CHEMICAL LAB ANALYST

Measurement of products specifications using GC, HPLC, FTIR, PH-meter, Refractometer, UV-VIS, Dissolution apparatus in accordance with international standard.

Compilation of data for documentation of test procedures and preparation of protocols, laboratory reports and SOPs.

Reviewed data obtained for compliance to specifications and report abnormalities.

Reviewed completed documents of other analysts and checking for good documentation practices (GDP), meeting specification requirements, and errors.

Communicated questionable and out-of-specification results to laboratory manager in a timely manner.

Provided analytical support to process validation group.

Performance of preventive maintenance, calibration and troubleshooting of analytical instruments as required.

PERSONAL SUMMARY

A highly talented and efficient quality personnel with good skills and experiences in quality management system, data integrity, GMP, GLP, instrumental and wet analytical techniques using right-first-time principles. Well trained with good understanding of the essentials of safety and quality.

Looking forward to being part of a dynamic organization where human resources is valued as a corporate asset that will challenge my problem-solving skills and allow me to continue to develop my knowledge and potentials.

EDUCATION

UNIVERSITY OF FLORIDA, GAINESVILLE, FLORIDA 2021 – 2023

MSc - Pharmaceutical Chemistry (In View)

FEDERAL UNIVERSITY OF TECH. AKURE, NIGERIA. 2006 - 2010

BSc (Hons) – Biochemistry

INSTITUTE OF SCIENCE LAB TECHNOLOGY NIGERIA. 2003 – 2005

Diploma - Science Laboratory Technology

CERTIFICATIONS

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Good Documentation Practice (GDP)

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