Resume Sample for QC Scientist – Analytical Chemistry

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Resume Writing Example for QC Scientist – Analytical Chemistry | CV Format

QC Scientist – Analytical Chemistry – GE Healthcare

Worcester, MA

Authorized to work in the US for any employer

Work Experience

QC Scientist – Analytical Chemistry

GE Healthcare

Marlboro, MA

August 2011 to Present

• Perform cGMP Quality Control Testing for multiple projects 
• Write protocols for and manage in-house stability program according to ICH guidelines 
• Support operations in QC Chemistry to ensure safety, identity, potency of products in accordance with FDA and ICH guidelines 
• Coordinate outsourced testing as required 
• Represent QC on project teams and coordinate QC activities with other departments to meet project deadlines 
• Collaborate on qualification and technical transfer protocols from Analytical Development to QC 
• Maintain and improve tracking systems associated with databases for sample receipt, analysis, reagent preparation, stability pulls and work scheduling 
• Maintain trending systems for QC results 
• Support laboratory functions including set-up, qualifications, calibration and maintenance programs 
• Participate in writing OOS/OOT, CAPA, deviations and laboratory investigations 
• Write, review and approve SOP’s, test methods, test records, and technical reports to ensure compliance with site, corporate and regulatory requirements 
• Peer review Environmental Monitoring data 
• Oversee and train less senior analysts 
• Ensure all QC activities are QC compliant and meet high scientific standards

Quality Control Analyst III, Chemistry

Alexion Pharmaceuticals

Smithfield, RI

February 2007 to July 2011

Perform procedures in the following areas: gel electrophoresis with staining and densitometry, HPLC applications, spectrophotometric applications and compendial methods such as pH, Osmolality, particulates and turbidimetry 
• Perform technical transfer of HPLC, spectrophotometric and gel electrophoresis assays 
• Perform assay trending analysis 
• Develop test methods, qualification and validation protocols and reports as assigned 
• Organize self and others as required to achieve project objectives 
• Support manufacturing activities such as: testing to support process validation and hold studies 
• Perform testing for in-process, drug substance and drug product release and stability samples 
• Recognize aberrant test and sample conditions and to prepare the necessary OOS and OOT reports 
• Investigate and troubleshoot technical issues 
• Perform all job functions in compliance with cGMP’s 
• Review laboratory documentation

Quality Control Specialist

Avatar Pharmaceutical Services, Inc

Marlborough, MA

January 2004 to February 2007

• Validate HPLC methods following regulatory guidelines 
• Utilize HPLC, dissolution apparatus, UV spectrophotometer, FTIR and Nova 8Electrolyte Analyzer 
• Review, analyze and interpret raw data and prepare final reports 
• Write and review SOP’s, validation protocols, and IQ/OQ’s for various instrumentation 
• Responsible for writing OOS reports and Validation Change Control procedures

Medical Technologist II

Athena Diagnostics

Worcester, MA

January 2001 to January 2004

• Perform PCR and DNA sequencing on patient samples 
• Utilized ABI 3100 and ABI 3730 DNA sequencers to analyze patient samples 
• Maintained proper quality control guidelines for patient documentation 
• Responsible for troubleshooting assay protocols

Clinical Assay Research Associate; QC Analyst II

Alpha-Beta Technology

Worcester, MA

May 1992 to September 1997

• Performed ELISA and chromogenic LAL on patient samples from Phase III clinical trial 
• Analyzed data and interpreted results of experiments 
• Performed HPLC, GPC, FTIR and wet chemistry techniques 
• Maintained laboratory notebook according to cGMP guidelines 
• Performed kinetic LAL, Bioburden and Gram-Stain to support Environmental Monitoring Program

Laboratory Technician II; Quality Assurance Technician

Biomeasure Incorporated

Hopkinton, MA

August 1986 to May 1992

• Performed HPLC, TLC, moisture analysis and IR Spectrophotometry on peptides 
• Protein purification utilizing a preparative HPLC system 
• Established and maintained an inventory control system for incoming raw materials 
• Responsible for activities involving cGMP, Quality Assurance and compliance to regulatory guidelines

Media Prep Technician

Genetics Institute Inc

Cambridge, MA

June 1985 to August 1986

Responsible for preparation of microbiological, agricultural and antibiotic media


Bachelor of Science in Biomedical Science

Framingham State College

Framingham, MA

May 1985


HPLC (10+ years), CGMP (10+ years), ICH (6 years), ELECTROPHORESIS (4 years), GEL ELECTROPHORESIS (4 years)

Additional Information

• Strong cGMP compliance experience 
• Develop and Manage ICH compliant stability program 
• Development, validation and transfer of analytical methods for biotherapeutics 
• Gel Electrophoresis including SDS-PAGE and IEF 
• HPLC applications including SEC-HPLC, Protein A, peptide mapping and oligosaccharide analysis

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