Quality Control Assurance

ALBERT W. MASSILA

Garner, NC **************@*****.*** 919-***-****

CAREER OBJECTIVE

Seeking a Quality professional position where I will be able to use my expertise in quality control/assurance

CORE STRENGTHS

• Performed successfully several test methods transfers and qualifications per cGMP

• Written and reviewed more than 200 investigations/deviations for accuracy and compliance

• Met consistently Key Performance Indicators requirements

• Have participated effectively in internal and regulatory authorities audits

• Been a conscientious leader

• Authored several SOPs/STMs and various technical documents

PROFESSIONAL EXPERIENCE

VALIDANT/COVIDIEN, Raleigh, NC 10/2011 – 02/2012

Senior QA Consultant Investigator

• Performed investigations/deviations per cGMP

• Participated in implementations of CAPA

• Perform presentations as needed to increase CAPA awareness

• Executed investigations write up activities as an individual contributor and a team player

• Performed documents revisions as part of CAPA implementations

AJINOMOTO, Raleigh, NC 12/2009 – 08/2011

Quality Control Supervisor

• Supervised seven employees

• Scheduled testing of in-process, stability, and final products

• Provided guidance to the Quality manager for quality system elements and continuous improvement

• Participated in customers and regulatory authorities audits

• Reviewed investigations for accuracy and compliance

• Performed testing related to Microbiology and Chemistry per cGMP

• Executed assay transfers and qualifications

• Provided Training to employees

• Participated in the implementation of ISO9000 guidelines

BIOLEX THERAPEUTICS, Pittsboro, NC 02/2009 – 08/2009

Quality Control Manager

• Performed the generation of monthly Stability reports and protocols

• Executed QC testing: SDS-PAGE, HPLC, and UV

• Provided assistance to the QC Director regarding process improvement and CAPA implementation

• Performed testing data review and Certificate of Analysis generation; final product release

• Authored investigations, various technical reports, and Standard Operating Procedures

WYETH VACCINES, Sanford, NC 04/2005 –

11/2008

Quality Assurance Specialist IV

• Reviewed Investigations related to QA, QC, Manufacturing, Engineering, and contract labs

• Performed Water For Injection batch reviews for release

• Evaluated CAPA for effectiveness as part of the Plant CAPA team

• Participated in internal and regulatory authorities audits

• Performed presentations to increase safety awareness

• Performed Training activities in order to improve the quality of investigations

• Reviewed Investigations related to QA, QC, Manufacturing, Contract Testing Labs, and Engineering.

• Batch WFI Release Data and Work Orders Review (Engineering).

• Performed/Participated in Documents Revision (Conformance Standard, General SOPs, and STMs).

DIOSYNTH BIOTECHNOLOGY, RTP, NC 07/1998 – 04/2005

Quality Control Supervisor

• Executed the development of the DNA Threshold Assay

• Performed various assays, which included HPLC (SEC, Reverse Phase, HIC, and Peptide Mapping),

Western and Southern Blots, Restriction Enzyme Analysis, Polymerase Chain Reaction (PCR), Enzyme-

Linked Immunosorbent Assay (ELISA), and SDS-PAGE

• Subject Matter Expert on Cell Bank Services – responsible for entire Cell Bank Program Management.

• Scheduled Lab Calibrations/maintenance program of equipment

• Authored/Reviewed SOPs, technical reports, and STMs.

• Participated in the execution of instruments’ Operation and Performance qualifications, assays validation

and qualification.

• Wrote Investigations, Validation/Qualification Protocols and summary reports.

EDUCATION

BS in Microbiology-Minor in Chemistry Washington State University, Pullman, WA

ADDITIONAL PROFICIENCY

• Microsoft Word, Excel, PowerPoint

• Successfully taken the Six Sigma Red Belt I and II exams

• Qualification in Trackwise®, LIMS® and SAP®

• Crucial Conversation and NASA Human Performance Model Certifications

• Fluent in English and French

• Knowledgeable in the Lean Laboratory program

OTHER ACTIVITIES

• Volunteer my time regularly in Church activities

• Play soccer

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