Quality Scientist Resume Sample
Johnathon Boyer
689 Marjolaine Passage,
New York,
NY
+1 (555) 153 9595
Work Experience
Senior Quality Assurance Scientist
11/2017
-
PRESENT
Dallas, TX
- Conduct troubleshooting and validation for process improvement
- Write SOPs and DCRs as needed
- Serve as the point of contact between the Quality Control and Product Development groups to assist the Quality Control Manager with technical transfer issues
- Provide technical training to associates on flow cytometry, immunofluorescent microscopy, immunohistochemistry, and lab skills
- Follow experimental protocols and Standard Operating Procedures (SOPs) and comply with ISO requirements
- Perform flow cytometry, IHC, and IF testing on a variety of products such as protein and chemical reagents, buffers, antibodies, antibody kits, and cocktails through surface, intracellular, and multicolor staining
- Prepare primary cells and cultures of various cell lines
- Use, maintain, and update internal databases, such as FileMaker and others, in a timely manner
Quality Control Scientist
12/2013
-
10/2017
Philadelphia, PA
- Education: B.S. in Chemistry or related biological sciences
- Extensive knowledge of content processes in the field of scientific database production and maintenance
- Experience implementing and/or managing quality control processes and procedures
- Hands-on experience and ability to use scientific databases and workflow solutions
- Excellent communication skills in English including verbal, written and presentation skills
- Educated to PhD level in chemistry, pharmacology, biology, biochemistry or a similar, closely related discipline
- Work cooperatively within the QC department and with other departments to achieve project goals
Assistant Quality Control Scientist
01/2007
-
10/2013
New York, NY
- Perform cell culture and the setup of cell stimulations
- Generating data summaries and provide ETAs for product testing and outcome
- Assist Quality Control manager and supervisor with data review
- Do testing and/or troubleshoot multiple products simultaneously
- Work in a dynamic and positive team environment
- Developing and implementing quality management tools and training materials
- Using global gap assessment/management tools to create a clear roadmap to full compliance to all global Q&FS
- Leading and facilitating programmes designed to gain/maintain LRQA QMP compliance and accreditation to selected external Q&FS-related standards
- Acting as an internal auditor and facilitating external auditor visits
Education
Waynesburg University
2003 - 2007
Bachelor's Degree in Chemistry
Professional Skills
- Strong technical leadership skills including the ability to coach and mentor less experienced employees.
- Strong analytical technical skills and experience with testing QC methods and concepts
- Demonstrated effective communication skills and the ability to work effectively with large multifunctional teams
- Demonstrated effective communication skills and the ability to work effectively with large multi-functional teams
- Strong verbal and written communication skills, including the ability to communicate technical information to audiences of varying backgrounds
- Strong organizational skills with the ability to handle multiple conflicting resource requirements
- Have demonstrated analytical skills using databases and statistical software
How to write Quality Scientist Resume
Quality Scientist role is responsible for analytical, technical, software, leadership, organizational, events, database, multitasking, excel, databases.
To write great resume for quality scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Scientist Resume
The section contact information is important in your quality scientist 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
- Telephone number
Work Experience in Your Quality Scientist Resume
The section work experience is an essential part of your quality scientist 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 quality scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Scientist resume experience can include:
- Strong technical writing and problem-solving skills
- Good problem solving skills with ability to make independent decisions
- Good communication, writing, and organizational skills
- Strong technical writing and analytical skills
- Good computer skills to include email Microsoft applications such as Outlook, Word and Excel
- Experience with current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs) is required
Education on a Quality Scientist Resume
Make sure to make education a priority on your quality scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality scientist 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 Quality Scientist Resume
When listing skills on your quality scientist 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 quality scientist skills:
- Demonstrate analytical and problem solving skills, apply broad knowledge and experience to address complex issues
- Demonstrated experience with use of data analysis and visual analysis Tools; experience applying data analysis concepts
- Demonstrated analytical skills using databases and statistical software
- Experience with managing and prioritizing multiple projects
- Pharmaceutical/biopharmaceutical laboratory experience working in a regulated (GMP) laboratory environment, preferably with QC experience
- Strong understanding of Good Documentation Practices (GDP) and high attention to detail
List of Typical Experience For a Quality Scientist Resume
1
Experience For Quality Control Scientist Resume
- Strong time management skills with the ability to prioritize and manage completion of multiple tasks/projects
- Possesses the appropriate interpersonal and communication skills to effectively interact with all areas both inside and outside the corporation
- Good communication, writing, and organizational skills, fluent in English
- Strong statistical and computing skills (Statistical Process Control, Excel, etc.)
- Responsible for maintaining Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP)
- Possess superior multitasking skills, be detailed oriented, and able to work in a high stress environment with deadlines
- Use of analytical techniques/ instruments, such as, HPLC, GC, etc. and computer skills
2
Experience For Quality Assurance Scientist Resume
- Effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Communicate effectively and ability to function well in a team environment
- Organization skills to support the department in the creation and approval of controlled documents in a timely manner
- Superb communication, collaboration, and leadership skills are required
- Industrial experience in a regulated chemical or consumer goods environment
3
Experience For Senior Quality Assurance Scientist Resume
- BS or BA in related field such as Biology and/or Microbiology required with 2 years experience OR MS with no experience necessary (project management
- Willing to perform low skill level tasks as well as high skill level tasks depending on the needs of the group
- Analytical methods development and validation experience (2 years)
- Developing creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Experience managing data in programs such as Excel, and performing statistical data analyses using programs such as R
- Perform analytical testing on raw materials, intermediate products, and finished goods adhering to GLPs, GMPs , and EHS requirements
4
Experience For Quality Control Systems Scientist Resume
- Relevant lab experience performing release and stability bioassay testing
- Experienced in accessing and utilizing Six Sigma and Lean tools
- Previous experience of working with blood typing processes and serology for example within Blood transfusion Services would be a distinct advantage
- Experience working in to standard operating procedures in a GMP/GLP environment is essential
- Validate and measure the outcomes of health management programs using SAS, R and other tools, to include provider data, claims data, membership data
- Bulk Product and Finished Goods testing
- Experience working in a cGMP Quality Control Laboratory
- Experience in dissolution testing, wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions
- Experience with ELISA testing, concepts and principles
5
Experience For Research Scientist, Quality Resume
- Proven track record in participating in projects and change management
- Experience is required
- Five (5) or more years' experience in the GMP industry
- Participate in QC Method Validation and Method Transfer activities
- Experience in Microbiological testing in a pharmaceutical or cosmetic laboratory is required
- Train new or less experienced personnel in SOP content, analytical techniques, and instrument use
- Assists with Development and Validation of new technologies and platforms for use in expanding genomic based service offering
- Demonstrate proper laboratory techniques
6
Experience For Scientist, Quality Resume
- Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
- Computerized database support and query development. LIMS (Laboratory Information Management System) and computer networking experience highly desirable
- Demonstrated ability to work in a highly collaborative environment
- Additional experience with ICP-OES, GC/MS, vibrational spectroscopy and chemometrics is highly desirable
- Demonstrated ability to communicate at all levels of an organization
- Experience in Complaint Investigation or Post Market Surveillance/QA appreciated
- Animal care and handling experience
- Demonstrated knowledge of BEC products (Hematology, Flow Cytometry, and Urinalysis)
7
Experience For Water Quality Scientist Resume
- Provide animal care in compliance with Animal Welfare Act, AAALAC guidelines, and cooperate with regulatory inspection agencies
- Good understanding of liquid and dehydrated media manufacturing process, aseptic and sterile fill process and systems
- Experience with Bioburden/growth determination systems, aseptic methods and sterilization systems
- Strong in application of technical principles, practices and procedures
- Statistical experience trending data (such as EM data trending)
- Experience with authoring SOPs, protocols, and reports
8
Experience For Senior Scientist, Reagent Quality Control Resume
- Building stability studies from LIMS templates and verifying the studies are built correctly prior to sample pulls
- Manages time efficiently and is able to re-order priorities as needed
- Understands the team organization and how the team cooperates with other teams in the area to jointly achieve objectives
- Experience in a regulated (Food or Pharmaceutical) Quality environment
- Experience with laboratory software systems such as Empower3, LabWare LIMS and Biovia LES is an asset
- Experience with Equipment Maintenance Program
- Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
- Possess and maintain a valid Colorado driver's license
9
Experience For Quality & Food Safety Senior Scientist Resume
- PhD and 0-4 years relevant experience, MS >6 years, or BS >8 years
- Running cell-based assays, designing and performing ELISA testing protocols, vialing finish products, and solution preparation
- Writing and revising Standard Operating Procedures and Standard Methods
- Cleaning and maintaining lab equipment, instrumentation and facility
- Understanding of the QC software packages used during routine work
- Taking the lead role in troubleshooting process and equipment problems
- Packaging component testing
- Tracking and close out of local risks
- Maintaining culture database, lineage and history internally
10
Experience For Product Quality Senior Scientist Resume
- Recommending equipment, supply purchases within the production areas
- Following Safety practices
- Keeping up to date with technical developments, especially those which can save time and improve reliability
- Working knowledge of general cGMP lab compliance
- Ensuring the laboratory is well-stocked and resourced
- Processing of complaints in accordance with established company procedures and worldwide regulations and standards
- Working knowledge of chemistry and analytical chemistry
- Ongoing development with licensee(s) and implementation an error correction procedure for each database asset
- Supporting and providing input to investigations including root cause analysis and documenting investigational activities
List of Typical Skills For a Quality Scientist Resume
1
Skills For Quality Control Scientist Resume
- Good problem solving skills with the ability to make independent decisions
- Excellent oral and written technical communication skills
- Excellent communication skills to ensure that complaint documentation is clear and concise
- Strong demonstration of leadership skills
- Investigational skills (experience with events and deviations such as ER, KLE, LIR, and MIR)
- Demonstrated experience with cell-based methods and ELISAs, and aseptic technique
2
Skills For Quality Assurance Scientist Resume
- Multi-task, effectively manage timelines, and great attention to detail
- Effectively presents results at internal meetings
- BS in a Life Sciences discipline and 5+ years of relevant experience OR MS in a Life Sciences discipline and 3+ years of relevant experience
- Effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines
- Experience in the pharmaceutical industry. Experience in Isolation Technology and/or Aseptic Area
- BS or MS in Biology, Biotechnology or equivalent along with 5 years experience proven confirmation of technical knowledge in cell culture and analytical assays
3
Skills For Senior Quality Assurance Scientist Resume
- Proven ability to organize and prioritize workload
- Fully bilingual (Spanish/English) communication skills, both written and verbal are required
- Two years relevant experience or combination of equivalent education and experience
- System administrator skills (such as performing monthly backups and password resets)
- Experience in a GMP environment in the Pharmaceutical industry and has a good understanding of GMP
- Work with limited supervision and function effectively in a team environment
- Working knowledge of supplement manufacturing, Good Manufacturing Practices (cGMP) as well as related quality protocols
- Experience of developing and managing auditing programmes
- Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
4
Skills For Quality Control Systems Scientist Resume
- Experience conducting and analyzing data using Empower software (Version III)
- Experience authoring / reviewing SOPs, test procedures and guidance documents in a GMP environment
- Experience writing & reviewing technical documentation
- Responsible for maintaining laboratory notebooks and records according to Good Documentation Practices
- Validates technical documentation distributed to customers, ensuring that the labeling is accurate and substantiated with data
- Willingness to positively embrace change and flexibility in adjusting to changing priorities
- More than 5 years of experience in Design Controls and Supplier Quality Management including electro-mechanical device and software suppliers
- Experience working in a GMP compliant lab
5
Skills For Research Scientist, Quality Resume
- Experience with authoring qualification reports
- Ownership of compliance-related projects including method verification/validation, method transfer and equipment qualification
- Experience with the following instrumentation (Ion Torrent, qPCR, HPLC, HPIC, Quantstudio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc.)
- Experience with the following instrumentation (Ion Torrent, qPCR, HPLC, HPIC, Quantstudio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc…)
- Direct experience of food product design and food manufacturing processes
- Have excellent understanding and knowledge of cell culture techniques and processes
- Experience with the following instrumentation (Ion Torrent, qPCR, HPLC, HPIC, Quant studio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc )
- Experience participating on a cross functional team
6
Skills For Scientist, Quality Resume
- Experience in working in FDA regulated environment
- Verifies / validates US CPO Quality Control data, while monitoring for trends and abnormalities. Reports and acts on data results
- Participate in OOS investigations via testing and good documentation
- Experience in a cGMP dietary supplement, pharmaceutical, food, or medical device manufacturing environment required
- With the Enabling Technology & Innovation Senior Manager, develop an effective and efficient procedure to monitor data quality within the ELSIP databases
- Knowledge of cGMP (current Good Manufacturing Practice)
- Teams with product development by conducting early look validation activities for the purpose of early detection of issues
7
Skills For Water Quality Scientist Resume
- Provides input to the team and ensures that testing demonstrates that a product meets the customer’s needs and intended use
- Good pipetting technique
- Demonstrated expertise in analytical techniques such as HPLC, GC, KF, FTIR, ELISA, etc
- Experience with qualification of lab equipment in a QC environment
- Maintains up to date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements
- Establish written procedures for validated assays
8
Skills For Senior Scientist, Reagent Quality Control Resume
- Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment
- Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems
- Experienced using standard quantitative and qualitative methods
- Experience in an analytical laboratory
- Performs qualitative and quantitative analysis of raw materials and finished goods
- Experience in a laboratory environment or Quality role
- Experience in handling biological or chemical samples and knowledge of GLP
9
Skills For Quality & Food Safety Senior Scientist Resume
- Relevant hands-on laboratory experience in an immunology or cellular biology setting
- Conduct troubleshooting and validation for process improvement
- Experience in performing ELISAs required
- Previous experience in IF, Flow Cytometry, and IHC
- Experience with mammalian cell culture and cell-based assays required
- Supports qualitative and quantitative analysis of raw materials and finished goods
- Manages time efficiently, and is able to re-order priorities as needed
- Experience collecting water quality and biological samples and use of associated equipment
10
Skills For Product Quality Senior Scientist Resume
- Experience working in the analytical chemistry profession
- Demonstrate flexibility, independence and initiative to perform successfully in a rapidly changing environment
- Experience with USP pharmacopeia testing is an asset
- Deep understanding of Good Documentation Practices (GDP)
- In industry, cGMP, with emphasis on analytical method development, validation, qualification and technical transfer as well as technical writing
- BA/BS in Microbiology/Biology with 6-10 year experience is required
List of Typical Responsibilities For a Quality Scientist Resume
1
Responsibilities For Quality Control Scientist Resume
- Work with limited supervision and function effectively in a team environment is needed
- Proven ability to organize, multitask and prioritize workload
- Clinical laboratory and cGMP Quality Control Laboratory experience
- Lead all reagent QC Method Validation and Method Transfer activities
- Write method validation protocols and reports for reagent QC
2
Responsibilities For Quality Assurance Scientist Resume
- Responsible for loss on drying and total solids testing
- Responsible to ensure good documentation practices are followed
- Following procedures to ensure proper calibration and maintenance occurs and is documented per GMP requirements
- Act as a contact for contract lab testing, including identifying and resolving any issues
- Support developing/expanding of new and existing facilities and lines as required for successful growth
- Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date
- Assists in documentation writing & revising including test methods, final product specifications, SOPs, etc. as required
3
Responsibilities For Senior Quality Assurance Scientist Resume
- Maintain specifications ensuring accuracy, completeness, and meeting product design requirements
- Responsible for writing and updating applicable SOP’s
- Develop/Support SPC charting and reporting efforts for laboratory data
- Maintain a safe working environment in accordance with Standard Operating Procedures (SOP’s)
- Work with relevant departments within the company including Quality, Product Development, Marketing, Regulatory and Legal to support the business
- Closely works with QC and QA to comply with cGMP during product batching and development
- Participate in cGMP audits of the facility, supporting QA management during internal and external audits
- Perform microbiological testing on raw materials, finished products and stability samples according to applicable procedures
4
Responsibilities For Quality Control Systems Scientist Resume
- Collect environmental/utilities samples and perform analysis according to applicable site procedures. Maintain environmental trending data
- Perform assigned projects and tasks; compile testing data and review testing results
- Handle OOS investigations for testing
- Manage multiple projects as assigned and assist with training Data Analysts
- Knowledge of PC spreadsheets, word processing, and database applications
- Ensure potential reportable events are submitted to site regulatory agency reporting
- Ensure supporting documentation is attached to complaints
5
Responsibilities For Research Scientist, Quality Resume
- Conduct reviews of complaint trending to determine CAPA eligibility
- Complete the following documents as required
- Provide training and share expertise with colleagues to ensure quality processes are followed
- Participate in quality audits of production activities, including but not limited to GEMBA walks
- Responsible for following laboratory schedules (as applicable)
- Responsible for serving on various project teams to fulfill activities as assigned
6
Responsibilities For Scientist, Quality Resume
- Individual is capable of independently troubleshooting analytical and instrument problems
- Individual is responsible for assuring adherence to Federal (FDA, DEA, EPA), OSHA regulations, cGMP's, SOP's, company policies and procedures
- Occasional weekend support to the Analytical Laboratory as needed for minor testing such as pH, viscosity and specific gravity is required
- Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results
- Able to interpret analytical data (including FT-IR, 1H NMR, MS)
- Write and revise SOPs including raw material, intermediate, and final product specifications
- Perform stability data trending
- To have an understanding of the performance of the assays responsible and support all critical reagents with guidance
7
Responsibilities For Water Quality Scientist Resume
- Completion of documentation following cGMP guidelines
- Support Investigations when necessary utilizing Method 1 and the DMAIC process for their own work
- Proficiency of the testing within the workgroup area
- Provide scientific understanding of ingredient functionality and review safety information for ingredients
- Extensively networked with raw ingredient suppliers, product development contract manufacturers, and testing laboratories
- Monitor existing (1st level) quality measurements and reports provided by licensee(s)
8
Responsibilities For Senior Scientist, Reagent Quality Control Resume
- Provide management with reporting on quality performance and trends for ELSIP databases
- Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision
- Clean and maintain laboratory areas and equipment according to procedures
- Perform Microbiology Lab activities as assigned by Quality Manager/Designee in order to achieve QC testing delivery goals
- Responsible for managing the day to day operation of the Quality Control Laboratory as it relates to microbiology processes and personnel
- Responsible for Quality Control testing of prepared media
9
Responsibilities For Quality & Food Safety Senior Scientist Resume
- Basic understanding of how stability is conducted in a GMP environment
- Conducts Engineering and other departments to troubleshoot instrument and reagents problems
- Analyzes data using statistical methods, interprets technical data, and promptly reports and documents issues
- For all ELSIP's assets, recommend improvements and adjustments to the governance, quality measurement and monitoring QA/QC procedures to ELSIP Management
- Manage and analyze data using accepted scientific and statistical methods, state and federal rules and policies
10
Responsibilities For Product Quality Senior Scientist Resume
- Conduct ICSR quality reviews per agreed procedures, under supervision/mentorship of Sr OP Analyst/OP Scientist as appropriate
- Development and production of operational performance metrics/dashboard for compliance, quality, productivity and cost-per-case for onshore, offshore and ad hoc vendor partners, as necessary
- Participation in functional and cross-functional project teams and meetings relating to operational performance analysis
- Qualify and perform maintenance on complex laboratory equipment
- Work independently with minimal to no supervision and direction
- Responsible for stability studies across all compounds in a compliance with ICH, WHO, company quality guidelines and SOPs in support of the company’s timelines and goals
- Complete verification of peer’s work
- Track completion of actions from external quality audits, quality investigations, deviations and change controls
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