Scientist, Quality Control Resume Sample

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Barton Hansen
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Work Experience


Senior Scientist, Quality Control
02/2016 - PRESENT
New York, NY
  • Manage a small group of staff in QC Compliance to ensure that the Analytical Chemistry laboratory is compliant to protocols, cGMP and regulations when providing high quality analytical support for manufacturing operations
  • Work with Quality Assurance to ensure that all applicable cGMP regulations are followed and properly documented
  • Lead and coordinate QC compliance life cycle projects
  • GMP experience in pharmaceutical, biopharmaceutical or similar industry desired
  • Strong technical writing and scientific reasoning
  • Perform computer based sequence analysis of synthetic genes
  • Assist with office and lab work when required
  • Address and report any problems in daily manufacturing and propose effective countermeasures
  • Communicate with rest of manufacturing team as needed
Scientist, Quality Control
02/2009 - 01/2016
Los Angeles, CA
  • Proposes and implements changes to maintain procedural requirements
  • Performs analytical test methods as written to support product/material release with minimal error
  • Proposes and implements changes to improve laboratory techniques and methodology
  • Can independently troubleshoot and resolve analytical techniques and instrument issues
  • Interprets experimental data for conformance with product/material specifications
  • Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles
  • Implements and ensures improvement ideas are completed to facilitate team objectives
  • Proposes and implements scientific protocols to determine exception event cause
  • Demonstrates strong analytical skills and logical thought process
Assistant Scientist, Quality Control
09/2004 - 12/2008
Houston, TX
  • Perform in-process quality assurance and quality control
  • Switch of shift to a four 10 hour days a week schedule likely once training is completed
  • Revises procedures as necessary and provides support for department.
  • Collaboratively conducts work/projects aligning goals with project teams and company strategies
  • Strong knowledge of GMP, SOPs and quality control processes
  • Communicate and work independently and collaboratively with scientific/technical personnel
  • Alignment of best practices, interpretation of regulatory standards and tests execution is strongly valued within Biogen’s Global Quality Control network
  • Understands,implements,and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements

Education


Harrisburg University of Science and Technology
1999 - 2003
Bachelor's Degree in Biotechnology

Professional Skills


  • Excellent written and verbal communication skills, strong work ethic, and computer literacy
  • Demonstrated experience performing analytical testing with HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD and method validation
  • Think critically and demonstrate troubleshooting/problem solving skills
  • Strong technical writing, and oral and written communication skills
  • Strong math skills, scientific background, and attention to detail
  • Excellent skills in Microsoft Office, data analysis software, and other related applications
  • Strong “hands-on” laboratory skills in molecular biology and instrumentation are a desirable

How to write Scientist, Quality Control Resume

Scientist, Quality Control role is responsible for analysis, scientific, software, travel, research, design, manufacturing, auditing, training, statistics.
To write great resume for scientist, quality control job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Scientist, Quality Control Resume

The section contact information is important in your scientist, quality control resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Scientist, Quality Control Resume

The section work experience is an essential part of your scientist, quality control resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous scientist, quality control responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist, quality control position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Scientist, Quality Control resume experience can include:

  • Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error
  • Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines
  • Interfaces with key customers effectively, independently and within a matrix leadership environment
  • Work with Quality Control, Validation and Quality assurance team to validate equipment and IT systems
  • Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
  • Responsible for generating trending charts for monitoring method performance, product quality, invalid rate and/or stability

Education on a Scientist, Quality Control Resume

Make sure to make education a priority on your scientist, quality control resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist, quality control experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Scientist, Quality Control Resume

When listing skills on your scientist, quality control resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical scientist, quality control skills:

  • Critical skills include: strong organizational skills, strong problem solving skills, and ability to work within time constraints with attention to detail
  • Experience in Quality Control environment with a good understanding of applying cGMP
  • Experience in performing analytical method validation and supporting method transfer activities
  • Be able to communicate effectively verbally and in writing
  • Experience in performing equipment validation activities
  • Budgets their time effectively to carry out assigned tasks. Make recommendations for improvement

List of Typical Experience For a Scientist, Quality Control Resume

1

Experience For Senior Scientist, Quality Control Resume

  • Communicate effectively with people in other disciplines
  • Work experience in a Research or GMP Quality Control laboratory
  • Experience in classical Virology methods is highly desired
  • Support QC team with validations of new methods; update documents and procedures
  • Experience with flow cytometry, cell-based bioassays, and ELISA methodologies
  • Experience with method qualification and transfer activities
  • Support activities related to the transfer and validation of analytical methods
  • Related work experience with large molecules
  • HPLC experience (for example SEC, Reverse Phase, ion exchange)
2

Experience For Associate Scientist, Quality Control Resume

  • Resolves discrepancies and reports results
  • Performs and/or supports more complex test methods as written to support product/material release with minimal error
  • Understands laboratory techniques and principles performed
  • Make recommendations for process improvement
  • Reviews test methods, reports, data packages and audit trails to support product/material release
  • Helps maintain trend reports, which support departmental performance. Delete
  • Troubleshoot and maintain analytical assays
  • Review and approval of documentation related to calibration, preventive maintenance and IQ/OQ of selected equipment, coordinate new equipment set up and validation
3

Experience For Scientist Quality Control Microbiology Resume

  • Experience with method transfers, root cause investigations, and experimental design using fractional factorial in JMP
  • Coordinate and track activities of cross-functional multi-site teams to meet strategic goals, timelines, and analytical method validations and transfers
  • Experience in molecular detection of Mycoplasma is highly desired
  • Identify, develop and implement new analytical technologies including innovative solutions to complex technical and compliance issues
  • Contribute to CMC sections of regulatory filings
4

Experience For Associate / Scientist, Quality Control Resume

  • Broad background in chemical analysis with solid hands-on experience within U/HPLC analysis of large molecules as well as the capability of being able to absorb and utilize new knowledge quickly
  • Author, review, and approve technical protocols and reports
  • Expertise in real-time PCR development is highly desired
  • Experience with developing and validating QC test methods is highly desired, including the requirements for validation of analytical test methods per ICH Guidance
  • Prepare the chemistry / biochemistry labs for routine operations from construction through process validation/PPQ runs. Lead and manage supporting projects impacting QC
5

Experience For Scientist, Quality Control Laboratories Resume

  • Support method transfer activities from existing Biogen sites to Solothurn. Ensure the site is prepared for routine testing and operations. Support the day to day operations within the Central and WIP labs
  • Leadership experience on both strategic and operational level
  • Work cross functionally to support method investigations and revisions as required with the Global QC and Analytical Teams
  • Perform and interpret analytical data evaluations
  • Preparation and or review of analytical procedures, stability protocols, stability matrices, and stability final reports
  • Management of stability samples and chambers as needed
  • Participation in quality audits as needed
  • Provide complete and accurate records consistent with quality guidelines and GDP requirements
6

Experience For Pharma Scientist, Quality Control Resume

  • Interface with customers and across departments as needed
  • Train personnel and act as a technical consultant as needed
  • Establish user requirements for purchase, qualification of Kite’s QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state
  • Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval
  • Demonstrated ability to develop, coach, and mentor key employees
  • Review data generated by other analysts for correctness and compliance with cGMP standards
  • Support investigations such as OOT and OOS
  • Be able to establish and maintain work schedule goals
  • Lead, participate in the investigation or review of change controls, quality deviations and out of specification results
7

Experience For Assistant Scientist, Quality Control Resume

  • Represent Clinical QC on Product Quality Teams and to other stakeholders
  • Author and revise processes and procedures for analytical method and associated work streams
  • Lead teams to support deviations, investigations, CAPAs and change control activities as needed
  • Identify and lead teams for lean improvement activities
  • Familiarity with FDA, ICH and GMP guidelines
  • Familiarity with Part 11 requirements
  • Assist with deviation, investigation, CAPA and change control activities at Kite pharma and contract labs, as needed
8

Experience For Scientist, Quality Control Operations Resume

  • Develop, revise and review SOPs, protocols and technical reports
  • Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines
  • Provide technical expertise and leadership for the stability program of commercial/clinical products. This includes design of stability protocols, maintaining data, expiry dating for products, authoring stability sections for submissions, technical assessment of stability specification changes and stability investigations
  • Support stability strategy development for products across all modalities (biologics, small molecules, oligonucleotides and gene therapy)
  • Author internal technical reports and specific regulatory submission sections, technical assessments for specification changes and investigations
9

Experience For Scientist, Quality Control Resume

  • Subject matter expert for data analysis and statistics
  • In-depth knowledge of GMPs and global quality systems
  • Understanding of LIMS functions and capabilities and experience with MS Word, MS Excel, and MS Powerpoint, Preference for extensive experience with Labware LIMS
  • Knowledge of ICH Guidelines and FDA/EMA/Global regulations
  • Some fundamental knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of proteins
  • 10-20% of International Travel
10

Experience For Senior Scientist, Quality Control Resume

  • Some fundamental knowledge of cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of small molecules
  • Support inspection activities
  • Knowledge of cGMP’s
  • 10-20% of Domestic Travel
  • Spectrophotometric concentration determination
  • Annual Product Review
  • Relationship Management and Communication - Excellent written and verbal communicator with ability to facilitate/articulate recommendations and key decision points to functional teams and senior management; demonstrated experience reducing complex subjects to key points; ability to develop strong network across company. Ability to develop and articulate stability and specification strategies

List of Typical Skills For a Scientist, Quality Control Resume

1

Skills For Senior Scientist, Quality Control Resume

  • Demonstrated experience performing analytical testing with HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD
  • Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
  • Proven analytical method development/validation/qualification with HPLC and GC
  • BS: At least 14 years of related experience or equivalent combination of education and experience
  • MS: At least 12 years of related experience or equivalent combination of education and experience
2

Skills For Associate Scientist, Quality Control Resume

  • PhD: At least 4 years of related experience or equivalent combination of education and experience
  • Good technical understanding of analytical techniques required for the quality control of viral vector and cell products
  • Knowledge of analytical methods and strong ability to analyze and interpret data using appropriate stability statistical concepts
  • Experience in at least 2 of the following analytical techniques required: HPLC, CE-SDS, SDS-PAGE, ELISA
  • Assists with writing and performs validation assays per approved protocols
  • Experience performing a variety of antibody based assays for bulk materials, in-process materials, and finished products
  • Working in a regulated (GMP) laboratory environment preferably with QC experience
3

Skills For Scientist Quality Control Microbiology Resume

  • Prioritize and achieve goals and objectives
  • Related work experience
  • Demonstrated expertise in analytical techniques such as HPLC, iCIEF, KF, CE-SDS, etc
  • Job-related QA work experience
  • Experience of Quality control for cell and gene therapy or Biopharm products
  • Experience of regulatory interactions and regulatory documentation
4

Skills For Associate / Scientist, Quality Control Resume

  • Experience in Quality Control for pharmaceuticals
  • Experience with stability trend analysis software, such as JMP
  • Application of statistics in support of spec-setting, shelf-life setting, report authoring of APRs, CPV, etc
  • Co-ordinating, Authoring and implementing local quality systems
  • Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts
  • Participate in generating training module and instruction led training material
  • Responsible for training and mentoring staff on data analysis and statistical methodologies to support program objectives
5

Skills For Scientist, Quality Control Laboratories Resume

  • Understands test results and pursues clarification of unusual results. Develops and uses system for anticipating and recognizing errors
  • The opportunity to join a world-class company and participate in building up a next generation biopharmaceutical facility
  • A permanent contract with superior compensation, sustainable learning and great development opportunities in a fast paced multicultural environment
  • Take initiative to be involved in team activities and decision making
  • Support, involve and work with technology transfer team to ensure successful transfer and ongoing performance of analytical methods
6

Skills For Pharma Scientist, Quality Control Resume

  • Author/review analytical method, Equipment and laboratory systems ensuring alignment with GSK standards
  • Thorough knowledge of USP Compendium testing
  • Knowledge and understanding of biochemical techniques and analytical disciplines aligned to Cell culture, bioassays and/or PCR
  • GMP and Quality Management understanding
  • Lead and support troubleshooting for complex investigations in the QC labs
  • Ensure quality through adherence to GMP requirements. Assure adequate training to perform assignments
  • Review of analytical testing data
  • Responsible for QC’s training. Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Perform testing of in process samples, lot release and stability samples in support of cGMP activities
7

Skills For Assistant Scientist, Quality Control Resume

  • Write, review and revise QC standard operating procedures and analytical test methods
  • Assist with troubleshooting of analytical instruments
  • Share responsibilities with the team to support sample and equipment management, and assist in maintaining the QC lab and its systems in a cGMP compliant state
  • Provide technical support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory
  • Perform analytical testing in support of in-process, lot release, and stability
  • Represent Clinical QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations
  • Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures
8

Skills For Scientist, Quality Control Operations Resume

  • Responsible for contributing to key functional, tactical, and operational aspects of the Global Quality Operations group at Biogen
  • Contribute to major/critical manufacturing, laboratory, and stability investigations (deviations, OOS, cross-site, cross-functional, and external)
  • Provides technical support during audits / inspections as needed
  • Working in a GMP Quality Control Laboratory
  • This role is a 2nd shift opening
  • Performs assigned tasks with some level of supervision required
  • Specifications and associated change control the Stability program strategy
  • Support validation and perform routine analytical techniques used for the testing and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA etc
9

Skills For Scientist, Quality Control Resume

  • Lead, support and perform validation and routine analytical techniques used for the testing and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA etc
  • Act as Subject Matter expert for equipments, system assigned
  • Maintains their certifications as needed for assigned job tasks
  • Possess thorough theoretical and practical understanding and demonstrate hand-on expertise in Mass Spec, HPLC, CE, and/or other analytical/bioanalytical techniques. Be able to trouble shoot and identify resolution independently
  • Demonstrate excellent project management and time management skills including the ability to plan, prioritize and complete own work and project teams’ in a timely manner
  • Knowledge of regulatory requirements, such as current GMP regulations
  • Review and understand test data
10

Skills For Senior Scientist, Quality Control Resume

  • Understand and follow safety precautions and procedures
  • Collaborate across multidisciplinary teams and to work independently
  • Master of Science within Pharmaceutical Sciences, Biochemistry, Protein Chemistry, or Biology
  • Maintains certifications as needed for assigned job tasks
  • Maintains their certifications as needed for assigned job task
  • BSc or equivalent in Biotechnology, Biological Science or related discipline
  • Demonstrable ability to interact successfully with external auditors

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