Analyst, QC Resume Sample
Darrion Boehm
247 Kihn Ranch,
Boston,
MA
+1 (555) 442 0823
Work Experience
QC Micro Senior Analyst
04/2018
-
PRESENT
Dallas, TX
- Testing execution
- QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
- Compliance and quality systems (SOP revisions, input to quality systems records)
- Participate in training analysts; troubleshooting of test methods
- Experience in a regulated biopharmaceutical laboratory is essential. HPLC/UPLC and Empower experience is required
- Responsible for supporting a culture of Continuous Improvement by using MSD Six Sigma tools within the CoE in your daily work
- Coaching others by sharing your skill-set and expertise
Analyst, QC
02/2015
-
03/2018
Los Angeles, CA
- Performs environmental monitoring of process areas per procedural requirements
- Performs clean utility sampling and testing per procedural requirements
- Performs gowning qualifications of personnel entering process areas
- Performs aseptic qualifications of personnel performing aseptic operations
- Performs bioburden and endotoxin testing of raw materials, in-process, and final product samples
- Performs bioburden, endotoxin, and biological indicator testing for the validation of manufacturing equipment
- Performs laboratory investigations
Analyst, QC Micro
07/2011
-
11/2014
Chicago, IL
- To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements
- Analysis of bulk product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods
- Assay trend analysis, document revision and update
- General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc
- Conduct in-process testing for finished product
- Perform HPLC runs for raw material finished product and stability testing
- Ensure effective communication between production and QC
Education
Upper Iowa University
2006 - 2011
Master's Degree in Chemistry
Professional Skills
- Experience and ability to perform cell based assay methodologies including cell line transfection Experience maintaining mammalian cell lines
- Prior experience with raw material testing such as wet ID, spectroscopy, titration, pH, osmolality, and/or conductivity
- BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science, along with experience working in GMP virology or cell culture lab or related experience
- Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required
- Assist with design of method validations, executes validation studies including method transfer activities
- Intermediate knowledge of technical skills required for analytical chemistry
- Relevant laboratory experience or A.S. with at least 6 years of relevant laboratory experience is desired
How to write Analyst, QC Resume
Analyst, QC role is responsible for computer, credit, retail, training, manufacturing, design, compliance, programming, software, english.
To write great resume for analyst, qc job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Analyst, QC Resume
The section contact information is important in your analyst, qc 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 Analyst, QC Resume
The section work experience is an essential part of your analyst, qc 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 analyst, qc responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular analyst, qc position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Analyst, QC resume experience can include:
- Focuses on providing standard professional advice and creating initial reports/analyses for review by experienced team professionals
- Ability or previous experience working night shift
- Demonstrates initiative and ownership in resolving issues or challenges
- Performs bioburden and endotoxin validation testing of raw materials, in-process, and final product samples
- Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures
- Experience working with pDNA
Education on an Analyst, QC Resume
Make sure to make education a priority on your analyst, qc resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your analyst, qc 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 Analyst, QC Resume
When listing skills on your analyst, qc 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 analyst, qc skills:
- Revise and update standard operation procedures. Display good manufacturing practices and good laboratory practices at all times
- Communication – Effectively communicate with all levels of manufacturing and support staff
- BSc in Chemistry or a biological science, with 3 – 6 years’ experience, or equivalent combination of education and experience
- Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
- Experience working in a biopharmaceutical testing environment
- Experience with raw material sampling and testing
List of Typical Experience For an Analyst, QC Resume
1
Experience For Analyst, QC Raw Materials Resume
- Perform instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography
- Participate in investigations of OOS results and other related studies
- Write protocols and reports as necessary
- Plan and execute experimental tasks, obtain and interpret experimental data with minimal guidance
- Perform review of calculations, logbooks and other data to execute LIMS approval, lot release protocol and final product data authorizations or approvals
2
Experience For Analyst, QC Micro Resume
- Review, analyze, interpret and report data
- Verifies and enters approved results in LIMS
- Support department compliance and productivity goals
- Track time worked per project
- Evaluate data against defined criteria/specifications
- Prepare reagents and shipments
3
Experience For QC Bioanalytical Analyst Resume
- Maintain lab in an inspection-ready state
- Perform moderately complex test methods such as ELISA, etc
- Complies trend analysis and write associated reports for internal and regulatory use
- Ensure compliance with SOPs, FDA, cGMP and GLP regulations
- Perform required data analysis, review data of moderate complexity, interpret data findings, investigate issues and report abnormalities, troubleshoots analytical methods
- Participate in housekeeping performance and audits
4
Experience For QC Micro Senior Analyst Resume
- Participate in out-of-specification investigations and recommend corrective actions
- Draft and revise SOPs
- Perform method transfer and qualification activities
- Conduct routine and non-routine analysis of raw materials, in-process, finished product, and stability samples according to standard operating procedures (SOPs)
- Responsible for daily laboratory maintenance tasks
- Gather and generate data
- Ownership – Actively participate in self-development
5
Experience For QC Biologics Analyst Resume
- Accountability – Follow through on commitments, Situational Leadership or additional accountability tools
- Detail oriented – Able to complete required tasks and associated documentation with minimal error
- Actively participate in department / level meetings
- Escalate issues through the proper channels
- Live the Core Values
- Review status of supplies and reagents to ensure items are ordered as needed
List of Typical Skills For an Analyst, QC Resume
1
Skills For Analyst, QC Raw Materials Resume
- Experience with relevant testing techniques- HPLC (SEC, RP, SCX), Dot Blot, SDS-PAGE, ELISA, Vacuum Decay, etc
- Experienced with wet chemistry techniques, chromatographic and spectroscopic testing
- Uses previous experience, analysis and investigation, to identify the most appropriate option to solve a range of differing, but straightforward problems
- At least one year experience in quality control
- Industry experience, preferably in a cGMP environment
- GMP laboratory experience in a pharmaceutical environment
- Experience with non-conformance, CAPA, and change control systems
2
Skills For Analyst, QC Micro Resume
- Strong initiative, organization ability to work independently
- Build/maintain strong partnerships within a business team, and to contribute to cross-functional departmental network development
- Perform analytical work per method transfer/ validation programs
- Follow good documentation practices to ensure appropriate documentation of test results
- Beginning to have more of a contributory impact on team performance
- Testing and Review
3
Skills For QC Bioanalytical Analyst Resume
- Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation
- Administration of programs such as gowning, aseptic qualification, training, ordering, calibration, etc
- Manage sample disposition of incoming QC samples to support manufacturing and stability testing
- Performs gowning qualification of personnel entering process areas
- Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc
- Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues
- Conduct routine and non-routine analysis of in-process, finished product, and stability samples according to standard operating procedures (SOPs)
4
Skills For QC Micro Senior Analyst Resume
- Shift focus efforts depending on management requirements
- Ability to use instrumentation and instrument software, including but not limited to TOC,
- Perform a variety of analyses including computer-based instrumental analytical methods
- Intermediate professional role, responsible for delivery of professional activities while receiving a moderate level of guidance and direction
- Accountable for meeting own targets which impact the immediate work area
- This is a 2nd shift position working M-F, 2-10:30pm
- Familiar with following USP monographs
5
Skills For QC Biologics Analyst Resume
- Proficiency in MS Office products or comparable word-processing and spreadsheet applications is required
- An understanding of cGMP, CFR, and USP is required
- Performs aseptic qualification of personnel performing aseptic operations
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, deviations, etc
- Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions; fosters a positive safety culture
- Self-driven, hard-working attitude
6
Skills For Analyst, QC Chemistry Resume
- Some working knowledge in PCR
- Executes complex methods requiring difficult sample preparation or data analysis
- Work with Project Managers and QA to ensure timely testing and release of samples
- Inform supervisor upon observing out of specification results
- Write and review SOP’s and Testing Standards as necessary
7
Skills For QC Micro Analyst Resume
- Interact with clients as necessary regarding CGMP, tech transfer methods, or stability issues
- Coordinate sample shipments to client and outside testing labs
- Perform routine maintenance and troubleshooting on lab equipment
- Work under monthly report production deadlines
- Basic knowledge of laboratory safety practices
- Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows
- Attains a solid understanding of cGMP principles
- In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions
8
Skills For QC Bioassy Analyst Resume
- Considered Subject Matter Expert on routine and some specialized methods
- Follow SOPs and comply with cGMP regulations
- General knowledge of bioanalytical assays such as ELISA, HPLC, cIEF, Western Blot, OCR, and CGE
- Impact is generally limited to short-term team performance, occasionally on medium-term goals
- Understands and communicates fairly complex information within the specialization or recognized body of formal knowledge
- Determines a course of action based on guidelines and modifies processes and methods as required
9
Skills For QC Biologics Senior Analyst Seperations Resume
- Understands and communicates complex information within the specialization or recognized body of formal knowledge
- Work in teams and with different functional areas
- Ablity to work independently with remote supervision
- In a GMP chemistry laboratory in method development or equivalent
- Capable to lead and/or participate with multidisciplinary within the site or within the organization
- Capable to interpret statistical data
10
Skills For QC Senior Analyst Resume
- Personal Competencies: self-awareness, integrity, team player, innovative, and flexible
- Bachelors in Scientific / Biotech / Pharmaceutical field of study
- The incumbent often works for extended periods alone, up to 8 hours per shift
- Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner at all times
- Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures
- Review data for conformance to cGMP and specifications and assist with investigation of laboratory deviations
- Ensure quality and safety of manufactured products. Follows established safety and environmental guidelines and procedures for all work performed
- Analytical instrument qualification
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