Scientist, Quality Control Resume Samples

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J Lueilwitz

Jewel

Lueilwitz

97341 Emely Roads

Detroit

+1 (555) 501 9600

97341 Emely Roads

Detroit

Phone

p +1 (555) 501 9600

Experience Experience

Houston, TX

Scientist, Quality Control

Houston, TX

Kuhic, Carroll and Conn

Houston, TX

Scientist, Quality Control

Transfer assays (HPLC, CE, ELISA, etc.) to/from development/GMP laboratories both internally and externally within the BMS network
Act as a primary contact within Quality Control for technical assistance
Generate design of experiments, qualify and validate analytical test methods, including supporting documentation, protocols, reports, etc
Facilitate planning and delivery of transfer projects within the Quality Control Department
Strategically lead project management oversight activities
Track and communicate progress and results related to projects/activities
Schedule internal/external meetings and coordinate associated agendas

Los Angeles, CA

Scientist Quality Control Microbiology

Los Angeles, CA

Gerlach, Ziemann and Klein

Los Angeles, CA

Scientist Quality Control Microbiology

Ensure that the instrumentation in the WIP labs are prepared for each corresponding unit operation to be performed in manufacturing
Support all start-up activities for the new lab, e.g. definition and implementation of workflows and issuing standard operation procedures
Validation of traditional microbiological methods as well as automated and rapid state-of-the art methods, such as microbiological identification (PRC-based method), Bacterial Endotoxins Test (kinetic-turbidimetric and kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test
Implementation of all the testing methodologies related to microbiological Quality Control in the new Quality Control Laboratory and Work in-progress (WIP) laboratories
Alignment of best practices, interpretation of regulatory standards and tests execution is strongly valued within Biogen’s Global Quality Control network
Support training of the On-The Floor (OTF) Quality staff members that will perform routine tests execution in the WIP labs
Perform trouble shooting and root cause analysis in order to prevent reoccurrence

present

Houston, TX

Associate Scientist, Quality Control

Houston, TX

Hilll LLC

present

Houston, TX

Associate Scientist, Quality Control

present

Writes/revises procedures as necessary and provides support for department. Assists in troubleshooting assays
Perform parallel review of laboratory documents, may perform technical review of documents such as protocols, specifications, etc
Make recommendations for process improvement. Take initiative to be involved in team activities and decision-making
Assists in trending data to support assay performance
Execute laboratory work, schedule with input from supervisor or senior team member
Performs tasks as assigned by Supervisor or manager
Revises procedures as necessary and provides support for department

Education Education

Science Degree in Biotechnology

Washington State University

Science Degree in Biotechnology

Skills Skills

Strong time management skills with attention to details and desire to achieve team and individual goals
Excellent verbal and written communication skills (SOPs, professional reports, emails)
Some fundamental knowledge of cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of small molecules
Ability to proactively support project management coordination for projects and initiatives
Be comfortable working in a team environment and interacting with other team members within the group and various departments of the company
Ability to present project updates and communicate to large groups
Ability to work independently
Strong verbal and written communication skills
Strong interpersonal skills
Strong method troubleshooting skills and scientific understanding of protein chemistry

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Scientist, Quality Control Resume Examples & Samples

Transfer assays (HPLC, CE, ELISA, etc.) to/from development/GMP laboratories both internally and externally within the BMS network
Act as a primary contact within Quality Control for technical assistance
Generate design of experiments, qualify and validate analytical test methods, including supporting documentation, protocols, reports, etc
Facilitate planning and delivery of transfer projects within the Quality Control Department
Strategically lead project management oversight activities
Track and communicate progress and results related to projects/activities
Schedule internal/external meetings and coordinate associated agendas
Train and mentor laboratory personnel in basic and complex laboratory techniques
Perform routine sample analysis as required
Provide technical support during FDA and/or Regulatory Inspections
Work on assigned projects independently with limited supervision
Bachelor’s Degree in a scientific discipline (i.e. Biological Sciences, Chemistry, etc.) is required, or equivalent combination of education and experience
Minimum of 6-8 years’ experience in chemical, biochemical, and/ or biological analytical testing in the biopharmaceutical industry with emphasis in biologics biopharmaceutical industry required
Experience in the transfer/validation of analytical methods
Ability to proactively support project management coordination for projects and initiatives
Strong organizational skills required
Strong interpersonal and communication skills, collaboration/teamwork, and adaptive skills required
Ability to present project updates and communicate to large groups
Proficiency in Microsoft suite (ie. Word, Excel, PowerPoint, Project), Visio, Gantt charts required
Previous experience in a GMP setting required
Demonstrated knowledge of and ability to apply cGMP regulations; prior interactions with domestic and international regulatory agencies preferred
1601783

Associate Scientist, Quality Control Resume Examples & Samples

Drafts technical documents such as SOPs, COAs and protocols with direct supervision
Perform parallel review of laboratory documents, may perform technical review of documents such as protocols, specifications, etc
Perform parallel review, verification of actions and transcription
Trains, coaches or mentors on technical issues. Trains others on laboratory techniques
Bachelor’s Degree w/ 5+ years experience
Master’s Degree w/ 2+ years experience

Assistant Scientist, Quality Control Resume Examples & Samples

Experience operating, maintaining, and troubleshooting stirred vessel bioreactors and/or protein purification and/or molecular biology cloning and sequencing techniques
Experience writing standard operating procedures
General laboratory equipment experience, including micropipettes
Communicate effectively and follow detailed written and verbal instructions; ability to clearly communicate with supervisor and group members as necessary

Associate Scientist, Quality Control Resume Examples & Samples

Requires a PhD in Chemistry with research conducted in a relevant area
Strong understanding of separation science principles preferred
Excellent communication skills (both verbal and technical) and interpersonal skills are required

Scientist, Quality Control Operations Resume Examples & Samples

Serve as a technical leader and providing guidance to laboratory analysts with regards to instrument set up, testing and troubleshooting laboratory issues
Mentor Senior Chemists, Chemists, and Chemist Assistants. Responsible for supervising the work of Senior Chemists, Chemists, and Chemist Assistants to ensure testing of laboratory samples to meet commitments
Coordinate with Senior Chemists and project management to schedule assignments and projects
Provide direction and technical guidance in the initiation of analytical investigations. Organize and lead Analytical Investigations, as well as perform composition and review of related Analytical Investigation Reports
Perform data analysis and auditing analytical data. Prepare, review, and update laboratory analytical procedures, Standard Operating Procedures (SOPs) and guidelines
Foster a positive work environment through teamwork and collaboration. Lead by example through dedication and being steadfast to accomplishing the task at hand. Encourage professionalism at all times regardless of how challenging the task
Minimum of a Bachelor's degree in Chemistry or similar science discipline (or equivalent) and 2-4 years of experience. Strongly prefer 6-8 years of pharmaceutical laboratory experience. However, a combination of experience and/or education will be taken into consideration
Must possess knowledge of SOPs, USP regulations, Analytical Testing Techniques, cGMP, and OSHA regulations/procedures for disposal of organic waste and procedures for the safe handling of chemicals
The preferred candidate will have a broad knowledge of various laboratory areas, being functional in the following (but not limited to): Chromatographic techniques (i.e., HPLC, GC, TLC, Ion Chromatography, etc.), wet chemistry, and dissolution
The candidate should have experience with drug substance and drug product release and stability testing, analytical method validation and method development
Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, consensus gathering skills, organizational skills, and a working knowledge of Microsoft Office including Word, Excel, and Lotus Notes
Must be accurate, detailed oriented, team focused, and possess the ability to multi-task and work in a fast paced, high output environment

Senior Scientist, Quality Control Resume Examples & Samples

Responsible for planning, prioritizing QC testing activities at Contract Manufacturing Operations ( CMO) and contract testing laboratories
Represent QC business processes across the organization, particularly as it applies to method transfers, method qualification and method validation activities
Serve as Subject Matter Expert for QC Chemistry laboratory methods and procedures. Specifically, HPLC, SEC and SDS PAGE method validations, raw materials and stability requirements for biologics
Support and/or lead QC technology transfer working teams
Responsible for QC release and stability testing of GMP drug substances and drug product materials associated with global R&D and commercial programs, including development and implementation of stability programs and collaborative interactions with CMO/CTOs for scheduling and performance of testing
Responsible for reviewing CMO/CTOs control plans to ensure appropriate QC control measures have been implemented
Responsible for the primary review and analyses of GMP test results, preparation of interim and final stability reports, development of investigation protocols and reports, preparation of summaries and other documents for communication with regulatory agencies. Participate and, as applicable, make presentations in both internal and external reviews, including regulatory discussions
Responsible for planning, documenting and conducting investigations of test results and test method issues, co-management of GMP test method life cycle with Analytical Development, and assist with technical planning activities for process and product development and commercial strategies
Responsible for technical assessment of methods for compliance to GMP requirements, guidance documents, and analyses of critical quality attributes. Implement strategies for adding new GMP test methods and verify suitability for company materials
Assist with planning and execution of GMP sample management procedures, documenting transfers and facilitating material submission for release testing, stability studies and QA retains at CMO/CTOs. Responsible to maintain an inventory of controlled temperature shipping containers, provide shippers and monitor performance of units used to transfer APIs, product samples, and reference materials during manufacturing campaigns, release testing and stability study testing
Assist and monitor preparation, qualification, and provision of documented reference materials to CMO/CTOs for use in GMP testing procedures
Support supplier audit as the Microbiology SME
A Bachelor of Science in chemistry, pharmaceutical science or closely related field, and a minimum of 12 years of related experience in the pharmaceutical/biopharmaceutical industry or quality control environment. A thorough understanding of commercial QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred
A minimum of 4 years of leadership experience within a commercial GMP QC laboratory
Experience leading continuous improvement projects within QC laboratories
Experience with developing and implementing QC procedures and business processes
Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in analytical methods and instrumentation, and statistical methods for data analyses
Excellent skills in written and verbal communication of detailed technical information and research strategies, effective interpersonal skills in coordination and organization of internal and external resources for materials testing, and skilled in analysis of data and application of statistical tools

Senior Scientist, Quality Control Resume Examples & Samples

Serve as Subject Matter Expert for QC Microbiology laboratory methods and procedures. Specifically, bioburden and endotoxin method validations, microbial identification, environmental monitoring and sterility requirements for biologics
Responsible for reviewing CMO/CTOs microbial control plans to ensure appropriate microbial control measures have been implemented
A Bachelor of Science in microbiology, pharmaceutical science or closely related field, and a minimum of 12 years of related experience in the pharmaceutical/biopharmaceutical industry or quality control environment. A thorough understanding of commercial QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred
Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses

Associate Scientist, Quality Control Resume Examples & Samples

Performs test methods as written to support product/material release. Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
Understands, implements and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements
Understands, implements, and maintains their training certifications as needed for assigned job tasks. Accepts responsibility to complete assigned tasks as committed
Works with others to maintain a positive atmosphere to accomplish business objectives
Helps maintain trend reports, which support departmental performance
Performs tasks as assigned by Supervisor or manager
Can work in multiple laboratory functional areas as assigned by supervisors, managers. Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error
Minimum 5 years industry experience in cGMP laboratory
Bachelors in Science, preferably biology and/or chemistry
HPLC experience required, preferably Size Exclusion Chromatography, Reverse-Phase Chromatography and Peptide Map analysis
Required proficiency with Empower software
TOC analysis and UV/Vis Protein Determination required

Associate Scientist, Quality Control Resume Examples & Samples

Assists in writing lab Investigation reports
Performs test methods as written to support product/material release
Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements., implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
Will perform a multitude of laboratory techniques for which they are trained
Analyzes test data and evaluates results
Writes procedures with guidance
Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties
Assists in trending data to support assay performance
BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree
2+ years of related work experience

Assistant Scientist, Quality Control Resume Examples & Samples

Conducts routine and non-routine analyses of microbiology methods (bioburden, endotoxin, growth promotion) in accordance with standard operating procedures (SOPs) or compendial methods
Performs other lab support activities such as preparation of laboratory reagents, media release, and cleaning glassware
Completes and review laboratory documentation, assay data and LIMS data
Updates or revises SOPs and other controlled documents as required. Continuously review SOPs associated with this job function for compliance with cGMPs
Work on individual projects independently with general supervision
BS/BA degree in the biological or chemical sciences
0-2 years of related laboratory experience in the biopharmaceutical industry
Knowledge of biological and/or chemical assays
Knowledge of cGMP’s
1604608

Associate Scientist, Quality Control Resume Examples & Samples

Performs more complex test methods as written to support product/material release with minimal error
Understands laboratory techniques and principles performed. Interprets experimental data for conformance with product/material specifications. Understands, implements, and maintains a safe work environment for themselves and others in accordance with procedural requirements
Assists with writing and performs validation assays per approved protocols. Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error. Understands, implements, and maintains their training certifications as needed for assigned job tasks
Make recommendations for process improvement. Take initiative to be involved in team activities and decision-making
Accepts responsibility to complete assigned tasks as committed. Works with others to maintain a positive atmosphere to accomplish business objectives
Writes/revises procedures as necessary and provides support for department. Assists in troubleshooting assays
BA/BS in Chemistry, Biology or equivalent science degree
A minimum of 2 years of related ELISA work experience required, including but not limited to product specific binding ELISA, residual host cell protein and protein A ELISA, kit based ELISAs, and chemiluminscent ELISAs is required
Software experience preferred: SoftmaxPro, Parallel Line Analysis (PLA), Envision/Enspire, Vision Publisher, ThermoLIMS SampleManager
Equipment Experience preferred: Perkin Elmer Luminescence plate reader, Molecular Devices Plate Reader, single channel/multichannel pipettes (manual/automatic), UV Spectrophotometer
Validation experience preferred

Associate Scientist, Quality Control Resume Examples & Samples

A minimum of 2 years of related capillary electrophoresis (CE-SDS) work experience is required
Software experience preferred: 32 Karat, Empower 2, Vision Publisher, ThermoLIMS SampleManager
Equipment Experience preferred: Beckman 800Plus, single channel (manual/automatic)

Senior Scientist, Quality Control Resume Examples & Samples

Serve as the Subject Matter of Expert (SME) in Mass Spec related methods and technology in QC
Develop/optimize/qualify/validate Mass Spec methods for QC lot release/stability testing, and for raw material release testing, if needed. Author test method, method qualification protocol and report
Demonstrate the ability to resolve key project hurdles and assumptions by effectively seeking out and utilizing available information and technical expertise. Strategically incorporate relevant knowledge into individual project(s) as well as the overall program
Perform analytical testing (Mass Spec, HPLC, CE-SDS, iCIEF, etc.) and Quality investigations in support of cGMP activities. Maintain a high level of productivity in the lab
Share responsibilities with the team to support raw materials release, sample management and other lab related activities
Assist in maintaining the QC lab and its instrument in a cGMP compliant state
Provide relevant training on analytical methods to colleagues both internal and at contract labs
Represent QC function on analytical subteam

Associate Scientist, Quality Control Resume Examples & Samples

Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
Understands, implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
Accepts responsibility to complete assigned tasks as committed. works with others to maintain a positive atmosphere to accomplish business objectives
Support investigations

Scientist, Quality Control Resume Examples & Samples

Evaluate and possibly implement new techniques and technologies. Coordinate validation activities. Manages resources and timelines to complete projects
Leads projects, managing resources and collaboration internally and externally
Author and revise SOPs, method development and validation protocols/reports
As needed for a project, plan and direct the daily activities of individuals outside of reporting structure. Directed activities are usually limited to assigning, monitoring and reviewing progress, and accuracy of work; directing efforts and providing technical guidance on complex issues
Work on individual projects independently with no supervision. Make autonomous decisions on own work and assumed responsibility for work results of employees in areas of responsibility
Perform under cGMP practices. Document work clearly, accurately, and in accordance with cGMP
Collaborate with scientists both external and internal (Clinical Science and Technology, Process Biochemistry, Analytical Development, Research, etc.)
Provide technical leadership and training to junior staff
Contribute to general GMP laboratory operation and compliance
In-depth understanding of individual area of work and related disciplines. Actively maintains and expands knowledge
Displays technical and/or scientific insight in the design and execution of processes and procedures
Contributes to development of new methods or new technologies, drawing on growing interdisciplinary knowledge
Initiates new project proposals in pursuit of corporate objectives
Attend seminars and/or classes as necessary to support business demands
Strong spreadsheet, word processing, and database skills necessary to process and present technical data in a clear and concise manner
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
Demonstrate excellent written and verbal communication skills
Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations
Demonstrate excellent interpersonal skills including ability to effectively collaborate with staff from other departments
Demonstrate advanced computational skills

Scientist, Quality Control Resume Examples & Samples

Manage product specific reference standard programs for biologics and/or small molecules
Drive initiatives for RS activities (technical, tactical, strategic) providing for the continued development of the overall reference standard philosophy
Collaborate cross-functionally with AD, QC, QA, Regulatory, and Asset teams to select, qualify, and implement new reference standards
Provide project management for the implementation of new reference standards
Author, review, and approve controlled GMP documents, protocols and reports, change control requests, risk assessment, regulatory documents
Manage in-country test requests, facilitate shipping requests, and maintain reference standard inventory
Manage reference standard investigations, exceptions, and change controls
Author reference standard sections for regulatory filings and respond to regulatory questions
Participate in regulatory agency inspections and internal audits
Participate in asset team/sub-team meetings, as needed
Minimum of PhD +5 years experience in Reference Standards or QC Testing in the Pharmaceutical industry, with 2+ years technical and leadership experience
Minimum of MS +7 years experience in Reference Standards or QC Testing in the Pharmaceutical industry, with 2+ years technical and leadership experience
Minimum of BS +10 years experience in Reference Standards or QC Testing in the Pharmaceutical industry, with 2+ years technical and leadership experience
Knowledge of LIMS, MS Word, MS Excel, and MS PowerPoint
Knowledge of FDA/EMA regulations
Knowledge of analytical methods and the ability to analyze data
Experience in Trackwise, Oracle, and myCIMS would be helpful

Scientist, Quality Control Laboratories Resume Examples & Samples

Subject Matter Expert, SME, for QC-Methods Validation, laboratory Instruments & Software, data integrity and LIMS
Author and when required review validation documents, including QC-Method transfer, QC-methods verification, validation plans, protocols, reports, summary reports
Participate to the development and maintenance of the local site procedures
Manage validation projects; including managing time, resources and budgets; own associated change controls
Develop and justify the validation approach based on risk and a scientific rational
Co-ordinate qualification and validation execution activities, including external vendors and internal departments
LI-NS1
MONEU
BS degree in Life Sciences, Chemistry, Engineering or equivalent
Minimum 2 years’ experience in managing QC-Methods validation projects
Familiarity with current international regulatory regulations, cGxP requirements and best practices, including USP, Ph.Eur,, JP, 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP
Good kknowledge of pharmaceutical facilities and laboratory systems
Team player: ability to interact effectively with team and customers

Scientist, Quality Control Resume Examples & Samples

Perform testing of raw materials, intermediates and final products by following analytical methods
Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays
Track and test products according to Stability protocols
Work with internal and external resources to maintain lab in an optimal state
Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release
Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings
Monitor the GMP systems currently in place to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

Scientist, Quality Control Resume Examples & Samples

Perform testing of incoming raw materials by sampling materials, confirming specifications; conducting visual and measurement tests; documenting inspection results and generating COAs for material release
Coordinate sampling and organization of raw materials with third party laboratories (3PL) for material warehousing
Develop methods for incoming raw material testing and coordinate method feasibility and validation with external testing labs
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to raw material inspection procedures. Provide updates at daily and weekly meetings
Maintain and operate equipment and instruments supporting raw material testing, Density Meter, pH and Osmometer, Visual Inspection Station
Monitor and catalog defects identified during incoming inspection and manufacturing production

Pharma Scientist, Quality Control Resume Examples & Samples

Ensure compendia, non-compendia, and cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
Manage & execute PQ methods validation
Participate to risk assessments & risk management teams
Is the change control leader for the QC department for methods review or implementation, review and approve control documents, to evaluate impact on qualified systems and validated processes?
Maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements
Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing Methods validations/verification with auditors, and providing documentation
Establish and maintain effective relationships with internal team, customers and suppliers
Minimum 5 years’ experience in QC-methods validation
Experience in QC-Instruments purchasing & qualification
Good communication skills in English with laboratory, technical operations, QA, and outside vendor groups

Scientist, Quality Control Operations Resume Examples & Samples

Foster a positive work environment through teamwork and collaboration. Lead by example through dedication and being steadfast to accomplishing the task at hand. Encourage professionalism at all time regardless of how challenging the task
Must possess knowledge of SOPs, USP regulations, Analytical Testing Techniques, cGMP, and OSHA regulations/procedures for disposal of organic waste and procedures for the safe handling of chemicals. The preferred candidate will have a broad knowledge of various laboratory areas, being functional in the following (but not limited to): Chromatographic techniques (i.e., HPLC, GC, TLC, Ion Chromatography, etc.), wet chemistry, and dissolution. The candidate should have experience with drug substance and drug product release and stability testing, analytical method validation and method development
Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, consensus gathering skills, organizational skills, and a working knowledge of Microsoft Office including Word, Excel, and Lotus Notes. Must be accurate, detailed oriented, team focused, and possess the ability to multi-task and work in a fast paced, high output environment
Ability to add, subtract, multiply, and divide
Normal laboratory and manufacturing situations. Regular exposure to chemicals, solvents, fumes and/or gases. Works alone or closely with others. Requires extensive safety training and/or protective devices. Works with limited ventilation or with regular exposure to odors. High dust environment.Typically sitting at a desk or table. Intermittently sitting, standing or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements
Proficiency in speaking, comprehending, reading and writing English is preferred

Scientist Quality Control Microbiology Resume Examples & Samples

Acquisition and Qualification of the analytical instruments according Biogen and cGMP standards
Implementation of all the testing methodologies related to microbiological Quality Control in the new Quality Control Laboratory and Work in-progress (WIP) laboratories
Validation of traditional microbiological methods as well as automated and rapid state-of-the art methods, such as microbiological identification (PRC-based method), Bacterial Endotoxins Test (kinetic-turbidimetric and kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test
Analysis of Total Organic Carbon and Conductivity
Ensure that the instrumentation in the WIP labs are prepared for each corresponding unit operation to be performed in manufacturing
Support training of the On-The Floor (OTF) Quality staff members that will perform routine tests execution in the WIP labs
Perform trouble shooting and root cause analysis in order to prevent reoccurrence
Support all start-up activities for the new lab, e.g. definition and implementation of workflows and issuing standard operation procedures
Support the facility certification with respect to the environmental monitoring (EM), utility monitoring (UM) and compressed gas distribution validation. Once the EM / UM program is established and running, the Scientist Quality Control Microbiology will have core accountability for the program, associated monitoring/trending and technical support
Author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.)
Drive activities at the Solothurn site to adhere to the construction or operational schedule
Alignment of best practices, interpretation of regulatory standards and tests execution is strongly valued within Biogen’s Global Quality Control network
Minimum of 6 years of experience in regulated (bio)pharmaceutical quality control environment
Strong analytical skills with high knowledge of implementing analytical techniques according cGMP requirements
Prior experience within a cGMP Quality Control (Microbiology) function including equipment qualification and methods validation as well as EM/UM
Strong problem solving skills, ability to multi-task, working autonomously and cross-functionally
Project experience would be advantageous
Dual Language preferred with a preference for German and English

Scientist, Quality Control Resume Examples & Samples

Review data from batch release and stability programs conducted at CMO
Along with QC Manager and CMO, examines current analytical methods in order to investigate, create and potentially develop new and improved methods and technologies which can benefit ongoing programs
Evaluate data for trends indicative of product performance, method performance, or analyst performance
Fundamental understanding biopharmaceutical analytical testing, with specific emphasis on HPLC methods (including SEC, released glycans, etc), IC methods (including monosaccharides), plate based assays (included ELISA/HCP, enzymatic activity,and receptor binding)
Some knowledge of basic protein biochemical and biophysical techniques such as enzyme activity assays, receptor binding assays, cell based bioassays, ELISA, Western blot, qPCR, iCEF, CD, DSC, DLS
Experience working with CMO’s and CRO’s for methods transfer, method optimization, and data and report review
Some fundamental knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of proteins
Some familiarity with the USP, EP and other compendia
Skills in statistics and statistical analyses of data a plus

Scientist, Quality Control Resume Examples & Samples

Along with QC colleagues and CMO, examines current analytical methods in order to investigate, create and potentially develop new and improved methods and technologies which can benefit ongoing programs
Fundamental understanding quality control analytical testing, with specific emphasis on HPLC methods (RP), Particle Size Determination, physical properties (viscosity, XRPD)
Some fundamental knowledge of cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of small molecules

Scientist, Quality Control Resume Examples & Samples

Perform routine analytical tests for release of Kite Cellular Therapy Products
Participate in the transfer and qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to QC Commercial and to contract-testing lab. Validation of methods will be phase appropriate
Establish specifications and testing process of raw materials. Develop in-process and final specification system for drug substance and drug product of Kite cell therapy product

Scientist, Quality Control Resume Examples & Samples

BS or MS in life science field with 8+ years (MS) or 10+ years (BS) working experience in pharmaceutical or biotech field
Excellent analytical mindset and skills including hands on experience with analytical methods such as UPLC, SE-HPLC, RP-HPLC, CE-SDS, and USP compendial testing, etc
Strong method troubleshooting skills and scientific understanding of protein chemistry
Familiarity with regulatory filings such as IND, IMPD and BLA
Familiarity with regulatory guidance documents (ICH, USP, CFR, general guidance)
Prior working experience in a regulated environment (GMP, GLP, etc.) is not required but preferred
Strong time management skills with attention to details and desire to achieve team and individual goals
Be comfortable working in a team environment and interacting with other team members within the group and various departments of the company
Excellent verbal and written communication skills (SOPs, professional reports, emails)

Scientist, Quality Control Resume Examples & Samples

Develop a plan and execute laboratory work, plan/schedule independently using customer milestones and business objectives
Bachelor’s Degree w/ 7+ years experience OR Master’s Degree w/ 4+ years experience OR PhD w/ no previous experience to qualify for the Scientist level. B.S./B.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or M.S./M.A. in Biotechnology, or related field, with no prior experience; or Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work for the Senior Associate level
Experience with LC/MS is helpful
Ability to write SOPs, batch production records and reports independently
Ability to problem solve to initiate and execute/monitor corrective action
Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems
Ability to work with other groups to develop, qualify and transfer methods accordingly
Understand and independently apply GMPs to everyday work with regard to documentation and instrument use
Understanding and adherence to applicable regulatory guidances
Experience with HPLC, SDS-PAGE, cIEF, ELISA, Microbiology, pcr, and/or RT-PCR (as applicable) for the analysis of pharmaceuticals prefered
Responsibilities for the drafting and revision of stability protocols per ICH guidance and Client requirements
Write Certificate of Analyses, Product Information Sheets and Stability final reports. Data archiving and maintenance
Write, edit and review Standard Operating Procedures (SOPs)
Maintain lab equipment, including qualification and calibration
Ability to develop Proficiency with Trackwise (R) quality management software
Ability to cross-train on techniques across multiple groups

Associate / Scientist, Quality Control Resume Examples & Samples

Design and manage studies. Independently author stability protocols and collaborate with Sample Control and QC laboratories to ensure proper testing and reporting of stability samples. Manage moderately complex issues, barriers, problems to support team success
Possess thorough knowledge of methods for data trend analysis and stability data behavior. Perform technical review of complex analytical data, interpret data and author in-depth technically-sound stability reports/regulatory submissions independently. Provide technical leadership through effective project management, status tracking, data analysis, presentations, and communication. Approve data/reports for team in the area of discipline/focus
Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the Global Stability organization. Actively provide leadership and mentoring as needed to aide in the development of team/peers, self and team projects. Represent department in internal and external audits proficiently. Author response to regulatory questions with minimal oversight
Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional). Independently author stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) stability results. Alert Quality organization about potential issues and evaluate remedial actions. Provide innovative solutions to unique complex problems. Proactively identify technical gaps and areas for improvement related to quality or process and lead them through completion
Participate on Asset sub-teams and maintain thorough knowledge of CMC program for assigned products. Collaborate routinely with other line functions and sites as well as internal/external partners and lead cross-functional teams
Advanced knowledge of operations/quality systems/directives and apply the knowledge within the team/project management routinely
Excellent technical writing, presentation and oral/written communication skills
Author technically sound and highly complex reports, and approve data/reports
Provide leadership for complex situations/issues problem solving to effectively reach solution
Mature leadership approach and understanding of their personal communication style and manage that effectively
Accountable for measurable goals/targets in work area
Possess strong organizational skills with ability to multi-task and coordinate multiple activities in parallel
Good knowledge of FDA/EMA regulations and compliance
Mentor junior members of team in quality systems, process improvements
Formulate solutions/options for team and reach out externally to regulatory/global teams for alignment
Conduct impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations)
Leadership competencies include: Personal Drive, Decision Making, Communication, Building Strategic Work Relationships and Innovation