Quality Assurance

Print date: **-May-*****-May-**

Monsurat Ajagbe

**** ****** **. ********* ** 53562

Preferred Tel: 773-***-****

acphbu@r.postjobfree.com Vitae

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Monsurat O. Ajagbe

SYNOPSIS

Over threeeightnine years of pharmaceutical/ biotechnology analysis experience including

analytical method development, validation, and optimization experience of small and large

molecules.

Proficient in cGMP regulations, ICH and FDA guidelines interpretations and analytical data

review.

Review of analytical data, reports, protocols, methods and SOP’s for Quality and Regulatory

compliance.

Review of investigations, non-conformances and CAPAs

ASQ Certified Quality Auditor. Also about five years experience in Quality Control Laboratory in

Beverage industry.

EMPLOYMENT

JAN, 2014: PPD Middleton, WI Associate Group Leader

• Organize, schedule and make recommendations for production activities and needs, also

oversee daily operations to ensure quality and project timeliness, and assist in

preparation and implementation of company training programs.

• Ensure that projects are completed in a timely manner so that company revenues are

met and clients continue to be satisfied with the quality and timeliness of work

performed, the quality of work performed continues to meet or exceed company

requirements and production staff and needs continue to be developed to keep pace

with department goals and growth.

• Prioritize and track various method verification, validation, or optimization projects,

and notify client and leadership team of accomplishments and/or issues.

• Provide assistance inConduct analytical data review, validation protocol and method

review, and report generation. Also enhance leadership skills and act as role model for

department staff.

• Supervise and enhance performance and career development for a team of 3-5 analysts.

• Set annual departmental goals that align with the company's strategic objectives,

communicate these goals to staff, track performance, and mitigate performance gaps

against these goals.

• Identify and lead strategic or continuous improvement projects that enhance the

laboratory's quality, technical, or business systems.

MAY, 2010: PPD Middleton, WI Senior Quality Assurance Auditor

• Ensured the quality of laboratory procedures, data, and reports by evaluating for

compliance with analytical methods, protocols (validation and stability), standard

operating procedures, client criteria, and applicable FDA regulations.

• Reviewed analytical data, reports, protocols, and methods, auditing equipment

qualification, computer validation, general laboratory records, laboratory analysts

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training records, conducting in-process inspection, general facility, vendor, and

subcontractor laboratory inspections.

• Provided interpretation and consultation to project teams on regulations, guidelines,

compliance status, and policies and procedures

• Evaluated policies and procedures for compliance with applicable regulations/guidelines and

provide recommendations to management for continuous process improvements.

• Assist in training of new Quality Assurance staff

• Collaborated with departmental and cross-functional teams to address cGMP

compliance issues and complete projects as assigned. Develop and maintain effective

relationships with internal and external stakeholders which include regional and global

entities.

• Demonstrated prudent independent judgment to balance quality expectations and

other stakeholder needs.

• Participated in working teams to provide direction regarding quality and compliance

and QA department requirements as needed

• Reviewed investigations, non- conformances (Quality Events and Deviations) and CAPAs

via QAAD/ PARTNER from initiation to close out.

• Planned and conducted facility audits and in-process and laboratory inspections for

compliance with organization’s policies and applicable laws

JUN, 2005: Since

2005

MM/YY to Current: PPD Development, Middleton, WI (Job Title) : Responsible for

Senior Scientist Research and Development

• Project leader on multiple projects, including interaction with clients, review and

evaluation of data, writing reports and protocols, in compliance with cGMPs and

GLPs

• Independently performed complex chromatographic method development and

validation, by means of HPLC and GC.

• Prepared protocols, development and validation reports for clients. Managed assigned

projects and schedule available resources to meet deadlines. Participate in client

communications regarding establishment of project requirements and status of

projects.

• Mentored and trained associate and assistant scientists.

• Performed various types of protein characterization assays including, SDS-PAGE, 2-

dimensional electrophoresis,Western Blots, ELISA, Bradford assay, Kinetic assays,

Osmolality, Peptide Mapping, IEF, SEC.

April, 2003: Responsibilities include performing a variety of complex sample

preparation analysis procedures to quantitatively measure pharmaceutical

compounds in a variety of formulation.

Evaluate method development/validation techniques being utilized and

offer suggestions to improve efficiency.

Independent performance of complex laboratory analysis of pharmaceutical

compounds on a wide range of analytical instruments (HPLC, GC, UV, IR,

particle size (Malvern).

Since04/2003 -

12/2004

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MM/YY to MM/YY: Neo Pharm Inc. Waukegan, IL

Research Associate

• Supported in the development of critical parameters for liposomal formulations/ products.

Provided analytical support using HPLC (DAD & ELSD) and wet chemistry, for In-process,

Entrapment Efficiency, Clinical trial and cGMP samples (Lyophilized and liquid

formulations).

• PerformedPlanned and methodconducted method development, validation and transfer. .

• Wrote Prepared and distributed tTechnical reports and protocols.

Reviewed stability data.

April, 2002: 04/2002 -

04/2003 American Pharmaceutical PartnersAPP Melrose Park, IL

Quality Control Chemist

• Applied analytical technique/instrumentation to assure batch uniformity and integrity of

incoming raw materials, in process and stability products.

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• JAN, 2001:

Applied analytical techniques/instrumentation to assure batch uniformity and integrity of

incoming raw materials/in process/stability/finished products by performing analytical testing

of products using HPLC from Waters and Agilent with Millennium, Empower and

Chemstation Software, GC, AA, TLC, FTIR, UV-VIS, Autotitrators, Particle Sizer,

Osmolarity Instrument and general wet chemistry methods.

Managed laboratory operations and audited out of specification investigations.

Managed quality control laboratory operations with knowledge of cGMP, GLP regulatory

guidance on technology transfer from product development to manufacturing. Reviewed,

verified and approved test data to ensure product release in quality assurance.

01/2001-

03/2002 Phoenix Laboratory Hicksville, NY Hicksville, NY

Analytical Chemist

• Performed Raw Material and Product Analysis, determination of active ingredients in

various compounds and formulae using HPLC, AA, GC and UV spectrometer. Identification

of compounds, using the IR and monitoring of the biodisintegrationbio disintegration of

tablets and wet chemistry, Stability testing.

• Trained new laboratory personnel in methodology, laboratory techniques and use of

instrumentation.

• Conducted release rate testing, managed and assisted in administration of laboratory

operations.

• Coordinated with production and quality assurance department

• Conducted safety inspections, audits and inventory.

Supervised lab-technicians ensured that results not meeting specifications are promptly

investigated and applicable actions implemented.

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JUN, 19992002: One year as QC Safety Officer updated MSDS, conducted Fire

Drills and monthly safety meetings.

06/1999-

08/1999 USEPA Chicago, Illinois

Research Intern for Lake Michigan Group

• Compiled the Fish Consumption Advisories and the Chemical Toxins found in Lake

Michigan and its tributaries which will eventually be used in the production of the lake wide

Management Plan.

JUN, 1993: 06/1993-

03/1998 Consolidated Breweries Plc. Ijebu-ode Nigeria

Quality Control Analyst

• Conducted Raw material analysis and finished product analysis of alcoholic and non-

alcoholic products, e.g., determination of water hardness and softness, chloride test,

determination of bitterness, color Oxygen and CO2 content of product using UV

spectrophotometer, haze meter, oxy-tester, CO2and CO2 tester.

• Trained new laboratory personnel in methodology, laboratory techniques and use of

instrumentation.

Coordinated with production and quality assurance department.

Previous Relevant Employment

AREAS OF EXPERTISE

HPLC Analyses- Evaluation of potency of drug product; assay and impurity

methods.

EDUCATION

Roosevelt University Chicago, IL May 2005

•

MSc. Biotechnology and Chemical Sciences

•

University of Illinois Chicago June 1999

• Health Careers Organization, School of Public Health Summer Residential Program

University of Ibadan Nigeria

• BSc. (honors), Biochemistry October 1992

PROFESSIONAL DEVELOPMENT

Certificate of Qualification: Instrument Installation, Operation and Maintenance of Polymer

•

Laboratories Evaporative Light Scattering Detector

• High Performance Liquid Chromatography by LC Resources

• Certificate of Completion: GLP Training Course

• Member American Society for Quality – ASQ Certified Quality Auditor (12/01/2012-

12/31/2016 cert # 44220

• EDGE Certification –Nov. 2012

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Skills

Knowledge of word-processing, spreadsheet, and database applications.

Extensive knowledge of pharmaceutical research and development processes and

•

regulatory environments.

Knowledge of quality assurance processes and procedures.

•

Strong interpersonal skills.

•

Excellent problem solving, conflict resolution, risk analysis and negotiation skills.

•

Strong training capabilities.

•

Effective organization, communication, and team orientation skills

•

Ability to manage one or more areas of responsibility. Demonstrate experience in

•

executing quality strategy with minimal management oversight.

Effective written and oral communication, interpersonal skills, facilitation and

•

influencing skills with an ability to effectively work across the group and external

stakeholders.

In depth knowledge of cGMP and other regulations as required with a broad

•

knowledge of quality principles and industry trends.

Knowledge ofProficient in MS Office, PowerPoint, word-processing, spreadsheet, and

•

database applications.

PROFESSIONAL AFFILIATIONS

PUBLICATIONS

• Co-authored, “A Rapid Isocratic Method for Determination of Cholesterol and 1, 2-

Dioleoyl-sn-Glycero-3-Phosphocholine (DOPC) in Liposome-based Drug Formulations”.

Journal of Chromatography A.

References:

Katherine Keiser, PhD: Quality Assurance Supervisor

Biopharmaceutical Testing

PPD Inc., 8551 Research Way Middleton WI

Tel: 608-***-**** FAX: 608-***-****

Dan D. Hobson, Associate Group Leader

Biopharmaceutical Testing

PPD Inc., 8551 Research Way Middleton WI

Tel: 608-***-**** FAX: 608-***-****

Terri Strother, Senior Research Scientist

Biopharmaceutical Testing

PPD Inc., 8551 Research Way Middleton WI

Tel: 608-***-**** FAX: 608-***-****

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PRESENTATIONS

Employee Signature Date_ Date

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