6227 Walnut Avenue, North (410) 795-3080
Sykesville, MD 21784 email@example.com
Top–performing, solutions–driven professional seeks a new opportunity. Decisive and results–oriented with outstanding leadership and crisis management skills. An engaging, professional communicator with the ability to put others at ease, quickly building relationships based on mutual trust and benefit. Meets and exceeds goals and objectives.
Professional strengths and abilities include:
? New Personnel QA Training
? One year college level German teaching experience
? Fluent in English and German
? Cell Media Preparation for E. Coli, Streptococcus and Streptomycin
? Liquid Chromatography Such As HPLC, Gel Permeation and Ion
? Hazardous Waste Administration
? Raw Material Receipt, Testing and Release
? Batch Testing and Documentation
? Production SOP, Good Manufacturing Practices, Company Policies and Procedures and FDA/EU Requirements
? Reviewing and Approving Production and Process Control SOP’s
? Reviewing and Maintaining Deviations and Investigations
? Performing Internal Compliance Audits
? Maintain and Update Quality Assurance Files and Archives
? CAPA Investigations
? Generating Quality Assurance Metrics for QA Systems
? BS in Biochemistry and 6 Years QA Experience
? Building and Maintaining Professional Relationships
? Time Management
? Collecting and Assembling Product Data
? cGTP Certified
? cGDP Certified
? cGMP Certified
Proficient in the use of Microsoft Word, Excel, PowerPoint, the internet and email.
PHARMACEUTICS INTERNATIONAL, INC. 11/09 – 5/10
Quality Assurance Associate
• On-Site sampling and qualitative analysis of pharmaceutical products generated during production event
• Final and In-Process review of bach production records
• Supervise production activities in order to ensure pharmaceutics are manufactured in accordance with current SOP’s and cGMP
• Perform and Participate in internal audits to ensure compliance with cGMP’s, SOP’s and company practices
• Issue, review and release of cleaning test records for equipment utilized during production event
OSIRIS THERAPEUTICS, INC. 3/06 – 5/09
Quality Assurance Associate-Compliance
• Ensure that all products are manufactured in strict accordance to SOP’s, current Good Manufacturing practices, company policies and procedures and FDA requirements governing the manufacture of pharmaceuticals.
• Review, test and release raw materials to production and document all materials received.
• Perform and participate in internal audits to ensure compliance with cGMP’s, SOP’s, company practices and procedures and government regulations.
• Ensures that Quality Assurance complies with all company policies and procedures and maintains accurate and up to date QA files and archives.
Ina Belling-Clusta Page 2
PROFESSIONAL EXPERIENCE (Continued)
• Review and approve production and process control SOP’s drafted and reviewed by operations.
• Train incoming personnel on applicable SOP’s and Quality Operations.
• Perform reviews and dispositions of Batch Production Records and associated documentation compiled by operations, Quality Control and donor eligibility to complete and satisfy lot release.
• Write, update and maintain Quality Assurance SOP’s.
• Review, maintain, create and edit investigations and deviation documentation.
• Assist in generating Quality System Metrics utilized by various QA systems such as deviations, CAPA’s and lot release.
ALPHARMA 8/04 – 8/05
Quality Assurance Assistant
• Collected, assembled and analyzed production data and compiled data for Production Development Reports.
• Initiated, performed and completed in detail investigations associated with the manufacturing process.
• Reviewed and approved In-Process documentation, Batch Production Records and support documentation.
• Provided lab support to pharmaceutical production Quality Assurance efforts.
University of Maryland Baltimore County 02/02 – 12/02
• Provided student assistance during required computer language sessions
• Created and integrated lesson plans emphasizing the development of verbal as well as written language skills
• Prepared, administered and corrected tests
• Kept attendance and grade record
University of Maryland Baltimore County 08/00 – 04/03
Chemistry and Biochemistry Department
• Coordinated meetings with faculty members to discuss future laboratory exercises
• Compiled all necessary materials needed for student laboratory experiments
• Supervised and assisted students during laboratory exercises
• Monitored chemical inventory
• Prepared solutions, solvents and standards for each laboratory
LABORATORY TECHNICIAN EXPERIENCE (DURING AND AFTER COLLEGE)
Laboratory Technician, Environsystems 4/03 – 6/03
Laboratory Technician, Howard Community College 2/00 – 8/00
University of Maryland, University College
Master of Science in Biotechnology, September 2011-current
University of Maryland, Baltimore County
Bachelor of Science in Biochemistry, 2002
Howard Community College
Associate of Arts in Computer Science, 1999