PATIENCE M. AMAH

**** ******** ******, **** ******* CO, 80526

Cell no.:832-***-****, Home: 970-***-****

EDUCATION:

B.Sc. Analytical Chemistry, Rivers State University of Science and Technology, Nigeria Feb. 1998

SKILLS: OPERATIONAL PLANNING AND MANAGEMENT

1Performed quality analysis of raw materials, intermediates, and stability samples.

2Capable of working independently with minimal supervision.

4Performed testing in collaboration with method validation and process development groups.

6Strong knowledge and understanding of current GMP regulations and industry standards regarding the validation

of raw materials for dietary supplement manufacturing.

7Ability to prioritize projects, make decisions and determine appropriate course of action.

8Responsible for talent management and retention.

9Identify personnel strength and recommend training to support career development.

10Suggest and Initiate Change control for test procedures.

11Ensure lab personnel adhere to implemented organizational policies.

12Perform testing in collaboration with Method and Process Validation groups.

13Driving higher profitability to improve organization by ensuring timely and accurate turn-around time on Raw

Materials, Finished products, Stability samples received in the QC lab.

14Ensuring laboratory personnel are conscious of doing it “Right the First time”. This helped reduce waste and

increase product quality.

Specialties:

• Involved in management and maintenance of Laboratory quality systems i.e. transfer of written Standards

from paper to Live on-line using LIMS.

• Use of software packages like Sample Manager, JavaScript, Oracle database to enhance the transfer of

laboratories online.

INSTRUMENTS USED:

HPLC Mass Spec for limit testing, Vankel Hardness Tester for solid dosage hardness testing, Conductivity meters, pH

meters, Spectrophotometer, Refractometer, TOC Carbon Analyzer, Beckman Densitometer, Moisture meters used for

the determination of moisture content in raw materials, Pycometer for determination of density of liquids, Centrifuges,

Karl Fisher Analyzers for water determination in finished products, PerkinElmer Dionex used for the extraction of

cations or anions in both raw materials and finished products, Agilent GC's, Shimadzu and Agilent HPLC’s,

Empower 2000, PerkinElmer DV2100 ICP-OES for heavy metal analysis of raw materials and finished products etc.

Types of GC's used:

•Head Space GC's by syringe injection technology using an FID detector (FID- Flame Ionization Detector).

Analytes detected were mostly organics

•Traditional auto sampler GC's using the technique of split or split-less injector using an ECD detector (Electron

Capture Detector)

Types of HPLC's used:

•Shimadzu

•Agilent

•Empower 2 by Waters

WORK EXPERIENCE:

Tolmar Pharmaceuticals, Fort Collins CO, 06/2012 – Present

QC Scientist I: 07/2014 – present

• Responsible for CAPA investigations and effectiveness reviews

• Responsible for providing training for lab personnel

• Responsible for impurities testing and helping find solutions for Out of trend and Out of Spec data

• Instruments trouble shoot and perform OQ/PQs

• Peer reviews

• Involved with internal audit performance

QC lab Supervisor: 04/2013 – 07/2014

• Responsible for delegating and assigning projects to self and team members.

• Responsible for communicating concerns and daily progress with management.

• Ensures that the generated shift schedules are followed to allow coverage for all operating needs.

• Responsible for communicating cleaning and in-process results to manufacturing after review.

• Review of peer data packages and process results.

• Reviews and updates of departments Test Methods and work instructions.

• Responsible for approving of time cards and personnel request for seven third shift personnel.

• Ensure personnel compliance with Stability and Finish Products Specifications and Protocols.

• Collaborates with Production to ensure timely delivery of assay results for finished products so COA’s can be

made prior to product shipping.

• Responsible for communicating with human resources to ensure personnel compliance with Safety

regulations, Company Procedures and Policies etc.

• Ensures that personnel are qualified and trained to perform job description.

• Initiates OOS and OOT investigations as appropriate per applicable Operating Procedures.

• Responsible for interviewing to hire new employees for the shift.

QC Analyst III:

• Responsible for testing Assays for both Finished Products, In-Process testing and Stability products of such

drug products as Atridox, Doxirobe, Erythromycin, Mometasone Furoate Cream, Ointment and Lotion,

Metronidazole Gel, Eligard, Lidocain / Prilocain, Imiqumode, Ketoconazole and Dapsone.

• Use of Chemstation and Chemstore to process result data before reporting.

• Peer review of data packages to aid in making COA’s before batch release.

• Use of Endeavour software to track Sample receipt and testing. This helps monitor projects and ensures that

deadline for sample releases are met.

• Involved in daily cleaning of Lab to ensure Lab safety to all personnel who use the lab and keeping up with

cGMP – (Current Good Manufacturing Practices).

• Involve also in mentoring of new Analyst to ensure they are in compliance with Industry Standards and

Company Policies.

• Ensures accurate and timely input of QC data to quality system e.g. Endeavour database.

Qualitest Pharmaceuticals, Huntsville Al, 04/2011-03/2012

QC Lab Chemist:

• Finish product testing for Assay, Impurity and wet lab Chemistry testing for API’s used in the manufacture of

drug products like Zopidem, Oxycodone, Acetaminophen, Baclofen, Lorazopam etc.

• Testing and release of Stability products to meet time lines.

• Review of data packages before batch release.

• Use of Track Wise system for writing investigations, process deviations, entering instrument issues and

Chemist errors.

Intertek

Caleb Brett, Red Bluff Blv., Pasadena TX 02/2009 – 03/2011

LIMS Validation Analyst

Functional Assistants:

•Configuration and deployment of Standard Test Procedures and Specifications in LIMS for local laboratories.

•Receive and resolve operational support requests pertaining to LIMS analyses and specifications as the first-line

user liaison.

•Ability to approach problems with a sense of ownership, enthusiasm and innovation.

•Troubleshoot problems associated with configuration, including interviewing users to understand the source of

problems and or business needs.

•Provide solutions to users from a position of knowledge as related to system capabilities, business / operational

experience and information gathered from interviews and research.

•Provide guidance and support to the other members of the support team from an operation perspective and in so

doing, improve their value to the department.

•Liaising with the operational community and where necessary providing assistance in educating the end user in

the areas of system capabilities and corporate configuration guidelines. Actually got a note of

recommendation from an end user of my ability to help them understand the process sent to my boss Steve

McArthur.

•Record and maintain data / documents associated with operational requests in hardcopy control logs, electronic

archives and web based sharing platforms ensuring traceability and conformance to quality system guidelines.

•Assist in preparing effective technical documentation, test scripts and end user training documents related to

work processes as assigned.

•Excellent organizational skills.

•Ability to multitask assignments.

•Ability to work with a high degree of independence and also making priority customer care service.

Biotics Research Corporation Rosenberg TX 03/2007- 09/2008

QC Supervisor

QA / QC Functions:

• QC Analyst, attached to the QC lab responsible for running ICP-OES for heavy metal determination in raw

materials and finished products.

• Assist in running HPLC for the determination of assay in both raw materials and finished products using

Empower.

•Review of data for HPLC assay of vitamins, raw materials and finished products.

•Also responsible for raw material release.

•Assist with raw material and finished product inspection before sampling to the QC lab.

•Responsible for modifying SOP’s to meet specific Industry and In-house test methods as needed.

•Performed investigations after out –of- spec results were turned in.

•Ability to be flexible, versatile and tolerant in a changing work environment while maintaining effectiveness and

efficiency.

•Excellent communication skills including speaking, listening and writing in a clear, thorough and timely manner.

•Ability to develop new ways to improve operations and create new opportunities.

•Execute internal GMP inspections and release raw materials tested in QC lab to production.

•Define the internal audit process and follow-up CAPA reporting and implementation; execute daily inspections

in Production, QC and Packing departments to ensure the operations are executed as per the highest cGMP.

•Develop and implement all calibration protocols.

People Management and External Communication:

1Plan for the recruitment and training of all technicians and research assistants; write job descriptions, define their

annual objectives, do bi-annual evaluation and then identify and retain talents.

2Designed and created a flexible professional, team working and high effective working environment.

3Maintain continuous and suitable communication with other departments.

4Develop Quality Excellence programs to improve the quality mindset attitudes towards higher quality and

efficiency in QA/QC department (Filling, QC laboratories supply etc.). This was a key performance indicator.

5Ensure that all QC and QA operations are executed in full compliance with company’s EHS policies and

standards. This was part of my biggest achievements working for BRC.

Pfizer Incorporated, Groton, CT. 2002 – Feb. 2007

Associate Scientist with Global Manufacturing: Associate Scientist, Production and Supply Chain API

Manufacturing 2004 – 2007

•Analyze pharmaceutical samples for manufacturing quality controls in the lab utilizing cGMPs.

•Use of HPLC in the identification, determination and stability assessment of drug substances via separation from

their potential degradation products and process related impurities for such drug samples as Neurontin, Zoloft

and Azithromycin.

•Perform troubleshooting of instruments and analytical techniques as required on shifts.

•Colleague Engagement Team from July 2005 – Feb 2007.

•Familiar with Method development and Validation.

•Very familiar with the Agilent, PerkinElmer and Shimadzu systems for running HPLC.

•Use of LIMS to evaluate raw materials, intermediates and finished products to meet specifications.

•Record and maintain data obtained through testing in a manner consistent with cGMPs.

•Maintain laboratory log books as required.

•Performed calibration checks, preventative maintenance and general equipment trouble shooting as needed.

WET LAB SKILLS:

•Performed various chemical tests on raw materials, in-process control and finished goods samples.

•Familiar with the following analytical processes: Cyanide extraction, Chloride extraction via Mettler titration,

Malvern particle size, LC, AAS, FTIR, UV, GC, TOC, HPLC, IC(e.g. Sodium-extraction, through the use of

Dionex).

Nigerian Liquefied Natural Gas Project (NLNG Bonny Site) 1997 – 2000

Personnel Manager: Meisei Marubeni

• Personnel Manager in charge of all local personnel.

• Responsible for documenting and achieving all information related with expert employees.

• Liaison person on behalf of the Company and host Community.

• Responsible for all employees training.

• Managed supply information for the office.

Institute of Pollution Studies, Port Harcourt Nigeria 1996 – 1997

Graduate / Laboratory Assistant

•Analysis of water sample, raw and treated wastewater, sludge and other by-products of

Waste water and treatment processes.

• Determined efficiency of plant processes to ensure that plant effluent met water

pollution control requirements.

• Conducted tests for settle-able solids, suspended solids, total solids, alkalinity, dissolved

oxygen demand and torpidity.

•Initiated changes in laboratory procedures and equipment in order to increase efficiency

of laboratory.

TRAININGS

HR behavior analysis training – March 2014

Chromeleon Version 7.2 training – Feb 2014

Tolmar Quality Systems training – April 2013

SmartSolve training – June 2013

SmartTrain training – August 2013

Endeavour training – June 2012

Chemstore and Chemstation training – June 2012

cGMP quarterly training – October 2011

Track Wise training on how to lunch lab investigations – August 2011

Super user training for Laboratory Information Management Systems (LIMS) – Nov 2009

Trace Element Analysis Seminar Series by Thermo Fisher Scientific on latest technologies for the ICP-MS, ICP-OES,

hi-res ICP-MS, isotope ICP-MS, April 2008

Biotics Corporation Leadership training program, Sept 2007

Pfizer 6-Sigma Method 1 training program, 2006

Pfizer Frontline Leadership training, 2005

Pfizer Corporate Policy, 2004

Pfizer cGMP training every six months from 2004

Contact this candidate