Specialist Quality Control Resume Sample

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Kiarra Moore
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Work Experience


Specialist, Quality Control
09/2017 - PRESENT
Houston, TX
  • Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise
  • Ensure lab compliance – which includes implementing procedures that enhance cGMP, GLP and safety
  • Independently structures and maintains complex data files for accurate reporting on Foreclosure Mitigation Grantees’ compliance and quality control audits so they can be maintained and provided to Congress, NeighborWorks® America staff, the U.S. Department of Housing and Urban Development, network members, and outside grant recipients
  • Thorough knowledge of GMP Pharmaceutical manufacturing
  • Work with autonomy and authority with the ability to make difficult decisions with little time for deliberation. Use of strong independent judgment and decision making abilities is required
  • Demonstrate troubleshooting and critical thinking skills
  • Highly productive, attention to detail, ability to manage time and prioritize tasks
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes
Specialist Quality Control
08/2014 - 03/2017
Dallas, TX
  • Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues
  • Independent decision making capability and ability to think conceptually and understand impact of decisions critical to product quality
  • Possesses excellent verbal and written communication skills; good interpersonal skills
  • Experienced in ensuring respectful interactions with individuals with diverse views or backgrounds
  • Work effectively on cross-functional and global teams
  • Participate in BI interactions with various governmental agencies/regulators and external auditors
  • Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating
Senior Specialist Quality Control
12/2008 - 05/2014
Philadelphia, PA
  • Physical Demands / Surroundings- Requires physical activity such as being able to lift approximately 50 lbs
  • Visual Demands - Eyestrain associated with the use of computer terminals
  • Level of Proficiency - Experienced level subject matter proficiency required with technical expertise such that corrective actions resulting from procedural deviations are effective in a timely manner and that any changes to processes and procedures follow relevant change control procedures
  • Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies
  • Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
  • Ensure compliance with procedures relating to area of responsibilities
  • Prepare initial documentation for run problems and error reports, e.g. LIS Testing Problem Investigation Form (formerly ISA’s) and deviations
  • Represent Quality Control as a primary member on NPI / TT teams. Interact with multiple functional areas, including Manufacturing, Process Development, Quality Assurance, and Facilities and Engineering, in a dynamic team environment
  • Provide technical expertise as a subject matter expert through collaboration with testing laboratories. Perform statistical evaluation of analytical data and trend analysis for multiple technologies

Education


University of Maine at Machias
2002 - 2007
Bachelor's Degree in Chemistry

Professional Skills


  • Strong interpersonal skills, along with outstanding verbal and written communication and problem-solving skills are essential
  • Strong computer operation skills including word processing, presentation, database and spreadsheet application skills
  • Strong computer operation skills including work processing, presentation, database and spreadsheet application skills
  • Excellent communication skills, facilitation and presentation skills
  • Demonstrated strong PC skills including proficiency in all Microsoft Office applications
  • Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal
  • Experience with equipment qualification, software validation, test method validation, and/or process validation

How to write Specialist Quality Control Resume

Specialist Quality Control role is responsible for database, organizational, computer, facilitation, microsoft, teamwork, scientific, interpersonal, power, analysis.
To write great resume for specialist quality control job, your resume must include:

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

Contact Information For Specialist Quality Control Resume

The section contact information is important in your specialist 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 Specialist Quality Control Resume

The section work experience is an essential part of your specialist 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 specialist 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 specialist quality control position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Specialist Quality Control resume experience can include:

  • Own analytical methods and standard operating procedures, and drive appropriate revisions. Design experiments for transfer and validation of analytical methods. Draft technical documents including test methods, protocols, reports, and standard operating procedures
  • Participate in regulatory inspections and internal audits through interaction with inspectors to present analytical testing methodologies, laboratory testing data, and investigations for Quality Control
  • Strong facilitation skills necessary
  • Detail orientedStrong organizational skills
  • Demonstrated leadership and teamwork skills, and ability to work independently
  • Excellent computer skills (i.e. Word, Excel, Power Point, Microsoft Office, SAP, etc.)

Education on a Specialist Quality Control Resume

Make sure to make education a priority on your specialist 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 specialist 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 Specialist Quality Control Resume

When listing skills on your specialist 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 specialist quality control skills:

  • Demonstrated effective written, communication, analytical and problem solving skills
  • Skill in working independently and to effectively interact with various levels
  • Excellent mathematics and writing skills
  • Strong time management, verbal and written communication skills
  • Experience with equipment qualification, test method validation, and/or process validation
  • Excellent oral and written communication skills and ability to interface with all levels of the organization

List of Typical Experience For a Specialist Quality Control Resume

1

Experience For Specialist, Quality Control Resume

  • Computer skills to include: Word, Excel, Power Point, Visio and Project
  • Strong understanding of production and materials operations
  • Addresses questions from Wilson Warehouse personnel for incoming goods with potential quality issues
  • Participate in protocol activities for technical and/or validation type work
  • Demonstrate a visible & tangible commitment to HSE, Quality, and the Merial Values in all work related activities
  • Partners with third party vendors and customers to ensure good GxP compliance for insourced and outsourced methods
  • Demonstrates detailed oriented attention in all facets of responsibilities
  • Lead laboratory method development efforts; Develop, validate, and implement new chemical or biological procedures to support CAH products and processes
2

Experience For Senior Specialist, Quality Control Resume

  • Reviewing and approving quality records
  • Monitors ANSI switching rules by determining if SI can use reduced component testing criteria or if normal testing is required
  • Responsible for guiding the business by using BPI, Lean and other process improvement methodologies
  • Works closely with Planning to insure urgent bulk and component packaging needs are met
  • Performs reverse traceability reports for working calibration standards, including corrective actions as deemed necessary
  • Project management support, leading efforts to drive timely execution of tasks. Developing execution strategy for equipment implementation
3

Experience For Senior Specialist Quality Control Resume

  • Oversees the training program and the onboarding of new quality specialists
  • Responsible for managing QC testing documentation of serials and active ingredients for QA review for release
  • Manage sample submission, testing and reporting for the stability program
  • Support product submissions by drafting file content and responses for inquiries from regulatory agencies
  • Maintain training compliance and proficiency in area of expertise within Quality Control
4

Experience For Specialist, Quality Control, Night Team Resume

  • Provide accurate and concurrent laboratory results using data capture forms and the computerized Laboratory Information Management System
  • Participate in the transfer of new analytical techniques, including documentation, equipment, reagents, consumable supermarket items, training and other identified requirements
  • Facilitate assay training to qualify new Technicians or the use of new equipment
  • Author and revise Standard Operating Procedures
  • Back-up scheduler for laboratory testing
  • Author and revise standard operating procedures (SOP’s)
5

Experience For Specialist Quality Control QC Metrics Resume

  • Participate in LEAN projects and continuously looking for best practices and areas for improvement
  • Understands and able to drive budgeting process
  • Analyzes all incoming materials such as bottles and caps, as needed
  • Performs review and approval of all component testing
  • Coordinates the sampling of all the compendial bottle samples that are tested each year for all Merck sites in the US
  • Ensures packaging lines do not go down due to SI unless there is a quality issue with a component or bulk material
  • Addresses packaging line calls that deal with component and bulk issues
  • Responsible for the sampling of all the compendial bottle samples that are tested each year for all Merck sites in the US
  • Provides scientific review of protocols, reports, study design and standard operating procedures
6

Experience For Principal Specialist, Quality Control Resume

  • Implement control systems to meet cGMP/GLP requirements where required including 21CFR Part 11 compliance
  • Provides technical guidance and training to others on SOPs and quality guidelines
  • Coordinate contract laboratory operations in chemical and biological clearance for use testing
  • Maintains working calibration standards
  • Manage the commissioning, qualification and maintenance of GMP equipment
7

Experience For Project Specialist, Quality Control Resume

  • Ensures the testing requirements are fulfilled with current GMP requirements, that product specifications are up to date
  • Is knowledgeable of site GMP procedures and is capable of interpreting intent and requirements within them
  • Stays abreast of emerging general GMP industry trends and regulatory agency guidelines
  • Author and revise Standard Operating Procedures, Guidelines, and Product Test Specifications
  • Maintain proper levels of supermarket inventory by ordering supplies
  • Manage service contracts for equipment requiring annual preventative maintenance
  • Assist with management of training documentation
  • Responsible for managing the sample activities (submission of samples to regulatory agency, retention samples)
  • Perform contract lab result entries by reviewing reported results are correct and accurate
8

Experience For Associate Specialist Quality Control Compliance Resume

  • Perform equipment troubleshooting, maintenance, etc. tasks
  • Collaborate with Quality, Manufacturing, Disposition, Contract Test Labs, and Regulatory Compliance staff in cross-functional teams
  • Monitor inventory levels and prepare critical reagents
  • Notify Manager of any laboratory problems and participate or support the timely conclusion of laboratory investigations
  • Perform environmental monitoring of the manufacturing and laboratory facilities including grade A, B, C and D environments, viable and nonviable air monitoring, water systems and compressed air and gases
  • Perform final product and stability testing on sterility, viability, dry wight, and other testing per product specification
  • Perform bioburden, TOC, conductivity, pH, endotoxin testing on pharmaceutical grade waters
9

Experience For Lead Specialist, Quality Control Resume

  • Performed Preventative Maintenance on laboratory equipment and instrumentation
  • Initiated deviation reports (SAP), determine root cause and establish CAPAs
  • Perform data review in LIMS
  • Performs analytical testing in the Quality Control laboratory on a variety of samples including drug substance, drug products, and/or incoming materials. Prevalent techniques include HPLC, UPLC, GC, sub-visible particles, titrations, and others
  • Provides support for quality, productivity and safety metrics in the facility
  • Reports and presents activities, issues and recommendations to senior management and executives
  • Ensures appropriate controls are in place to remove barriers that slow or prevent the successful attainment of process/produc tivity improvements
  • Develops and documents standard work processes
10

Experience For Specialist, Quality Control Editor Resume

  • Fully trained and trains new employees to the area
  • Performs bulk review and release in SAP
  • Authors all vendor quality notifications, internal complaints to other Merck sites for bulk material, and temperature excursions for bulk material, as needed
  • Updates SOPs and procedures as needed in the SI area
  • Coordinates the upkeep and testing of Merck-Wilson’s tailgate program. This includes adding new vendor’s to the tailgating program to allow the use of vendor pulled samples

List of Typical Skills For a Specialist Quality Control Resume

1

Skills For Specialist, Quality Control Resume

  • Experience in assay method development, optimization, validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products
  • Excellent skill in leading, motivating, influencing, and negotiating
  • Skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities
  • Skilled in organisation, planning, priority setting and time management
  • Skills in solving complex problems
  • Experience in a professional environment with any of the following: Quality Control, Quality Assurance and/or cGMP experience
  • Experience in executing phase appropriate method qualifications and validations
2

Skills For Senior Specialist, Quality Control Resume

  • Previous technical and / or analytical problem solving experience in vaccine or biologics development, and / or quality site experience
  • Previous technical and/or analytical troubleshooting experience in vaccine or biologics development, and/or quality site experience
  • Provides problem solving skills to support the resolution and documentation of investigations with timely closure
  • Lead transfer of Methods to and from the Canton site; lead design of method validations; and executes validation studies including method transfer activities
  • Previous experience with transfer and/or validation of analytical methods
  • Database and spreadsheet application skills- Familiarity with statistical tools and methods
  • Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities
  • Advanced skills in solving complex problems
3

Skills For Senior Specialist Quality Control Resume

  • Advanced scientific data analysis and interpretation skills
  • Project management facilitation skills
  • SAP, Tracelink, experience as a team lead or managerial experience
  • Testing experience with ANY of the following: HPLC, GC, UV, and/or IR
  • Executing Quarterly method invalid tracking report
  • In-depth knowledge of pharmaceutical manufacturing, testing and packaging, with strong understanding of regulatory requirements set forth in ICH guidelines
  • Knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility
4

Skills For Specialist, Quality Control, Night Team Resume

  • Evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines
  • Perform validation support testing of LAL, Biological indicators, and Bioburden and other testing as assigned
  • Invalid reporting and tracking
  • Lead technical transfer and method validation activities including generation of protocols and reports and support for ad hoc regulatory supporting studies
  • Trackwise / Quality Management Tracking System (QMTS) experience
  • Excellent proficiency in separation techniques including Size Exclusion, Reversed Phase, and Ion Exchange chromatography
  • Extensive knowledge of all tests including the development and validation of assays and the ability to perform all tests in specific area of responsibility
5

Skills For Specialist Quality Control QC Metrics Resume

  • Expertise in more than one scientific discipline and demonstrated success in applying to a wide variety of practical problems
  • Experience in one or more of the following: PCR, cell-based potency and TSCT assays
  • Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards
  • Works in a collaborative manner and is able to develop excellent working relationships with peers
  • Review testing documentation and LIMS entries for validity and accuracy of test execution and results
  • Experience in deviation methodology and method trouble-shooting
  • Experience in analytical method transfer and trouble shooting
  • At least five years of experience in the pharmaceutical manufacturing industry
  • Discover Student Loans Experience
6

Skills For Principal Specialist, Quality Control Resume

  • Demonstrated working knowledge of food safety and quality assurance frameworks, preferably SQF disciplines
  • Leads and facilitates the development and validation of new analytical methods as needed in alignment with ICH requirements
  • Performs special projects or tasks as necessary based on skill set and/or development goals and business needs
  • Operates Analytical Equipment, Perform Analytical tests, interprets results and documents findings in accordance with SOPs and regulatory requirements
  • Demonstrated ability to organize, coordinate and execute on details
  • Demonstrated ability to work across multi-functional lines within an organization and multi-task in a fast paced environment
  • Willingness to service and respond promptly to key partners and a demonstrated persistence to follow through to resolve issues
7

Skills For Project Specialist, Quality Control Resume

  • Understand, support and demonstrate the AMGEN values
  • Skill in evaluating and documenting according to Company and various guidelines
  • Experience with Operational Excellence tools
  • Demonstrated persistence to follow through to resolve issues
  • Demonstrated ability to work across multi-functional lines within an organization and multi-task in a fast-paced environment
  • Certification with SQF disciplines or previous experience
  • Experience in a Quality role in the biotechnology or pharmaceutical industry
8

Skills For Associate Specialist Quality Control Compliance Resume

  • CFR and Regulatory knowledge and/or experience
  • Demonstrated success in independent judgment, technical proficiency, scientific creativity, collaboration with others in a cGMP environment
  • Manage multiple priorities and tasks in a dynamic environment
  • Strong technical knowledge and high level of technical performance
  • Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation
9

Skills For Lead Specialist, Quality Control Resume

  • Working knowledge of GMP, NDA, or related regulations
  • Working knowledge of GMP, NDA, related regulations
  • Gowning certification required
  • During audits, serves as the SME for Supplies Inspection and addresses auditors as needed
  • Tracking to completion of the corrective actions activities
  • Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data
10

Skills For Specialist, Quality Control Editor Resume

  • Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics
  • Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans
  • Develop new metrics reporting outputs and spreadsheets to enable greater efficiency and alignment with metrics control plans and staffing resource modeling
  • Provide reports, data analysis and ensure flow of communication between technical groups including following up and resolving issues that arise
  • Raw Material Testing, Chromatography (HPLC/GC), Testing per Pharmacopeia (USP/EP/JP)
  • Knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products
  • Exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
  • Interact with other functions on a technical level for various projects including but not limited to Quality control and Manufacturing Technology

List of Typical Responsibilities For a Specialist Quality Control Resume

1

Responsibilities For Specialist, Quality Control Resume

  • Initiates, coordinates, and authors vendor quality notifications, internal complaint quality notifications to other Merck sites, and temperature excursion quality notifications for incoming bulk. With management input, make decisions on component and bulk disposition as it relates to these investigations
  • Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility
  • Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products
  • Experience with writing procedures/ reports and execution of laboratory test is desirable
  • Assists with equipment qualification / validation activities, including maintenance
  • Troubleshoot and provide advice to clients on equipment validation and maintenance issues
  • Author, review and approve SOP’s, Forms and validation related documents
  • Building Strategic Working Relationships—develops and uses collaborative relationships to facilitate the accomplishment of work goals
  • Provides support to QC management, including the coordination and scheduling of routine testing, project management and lab operations
2

Responsibilities For Senior Specialist, Quality Control Resume

  • Manage technology transfer information flow, assisting in the acquisition of capital equipment and qualification and assist in release testing as necessary
  • Manage tasks associated with the preparation, analysis and tracking of reporting key performance metrics to management and cross functional area teams
  • Site data compilation and review for method trending and performance monitoring of analytical methods
  • Responsible for performing root cause analysis investigations and translating into actionable actions to prevent recurrences
  • In depth knowledge of current regulatory requirements for chemistry in support of cGMP operations supporting clinical and commercial manufacturing
  • Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products
3

Responsibilities For Senior Specialist Quality Control Resume

  • Quality at the source utilizing on the floor real time batch record review, disposition batch record review, disposition and in process auditing
  • Perform environmental monitoring and utility testing of the facility
  • Performs environmental monitoring during fill operations (as necessary)
  • Applies expertise to support change and risk management, including application of scientific and technical innovation
  • Review record keeping and documentation of laboratory equipment maintenance
  • Interview and recommend the employment of technical and professional supporting staff
  • Physical Requirements: Requires vaccination against different viruses including Vaccinia virus
4

Responsibilities For Specialist, Quality Control, Night Team Resume

  • Perform complex assay and instrument troubleshooting
  • Ensure the accuracy of the metrics used for analytical method trending and corporate / site / department management reviews
  • Additional activities such as owning Change Control and Non-Conformance records
  • Independently responsible for following through on multi-site action items
  • Provide SME trouble shooting support as required
  • Provides instructor led training of Calibration Software and Calibration procedures to BD employees
  • Provides training to Calibration Technicians on Calibration procedures, work instructions and quality guidelines
  • Conduct method transfer activities following Merck processes and Standards
  • Lead sample reconciliation in the QC area for stored processing/stability samples
5

Responsibilities For Specialist Quality Control QC Metrics Resume

  • B.S., M.S., Ph.D. in appropriate Biological science, Biochemistry, Chemistry or Engineering field
  • Communicate within all levels of CAH regulatory organization including Sr leadership
  • Performs general laboratory support activities including reagent preparation, equipment maintenance, etc
  • Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics
  • Proficient at maintenance, troubleshooting and operation of equipment in area of expertise
  • Interact with regulatory agencies both orally and in writing
  • Advanced knowledge in data trending and evaluation
  • Understand, apply and evaluate basic lab and QC testing principles
  • Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement
6

Responsibilities For Principal Specialist, Quality Control Resume

  • Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs)
  • Perform various microbiological / analytical testing procedures per Quality control batch records and stability protocols
  • Takes a structured, analytical approach to problem solving
  • Final Product and Stability Testing
  • Assists in the training efforts of the laboratory personnel
  • Addresses all questions from other SI employees for their clarity on procedures and potential issues
  • Works with CMC on updates to filings and filings for new components to insure Merck Wilson’s alignment
7

Responsibilities For Project Specialist, Quality Control Resume

  • Performs the Quality approval for component discards on FA33’s
  • Address unexpected issues that arise. For example upon discovering SI was out of alignment with a filing, initiated a QS update to place Merck-Wilson in line with a Legacy Schering product’s filing that was transferred to Merck-Wilson
  • Performs weekend/night/holiday coverage for SI
  • Supports SDPM on vendor investigations. This includes multiple visits to vendors to insure vendor quality and resolution to quality notifications
  • Approves all vendor quality notifications, internal complaints to other Merck sites for bulk material, and temperature excursions for bulk material, as needed
8

Responsibilities For Associate Specialist Quality Control Compliance Resume

  • Approves SOPs and procedures as needed in the SI area
  • Responsible for the approval and upkeep and testing of Merck-Wilson’s tailgate program. This includes adding new vendor’s to the tailgating program to allow the use of vendor pulled samples
  • Approves vendor quality notifications, internal complaint quality notifications to other Merck sites, and temperature excursion quality notifications for incoming bulk. Make decisions on component and bulk disposition as it relates to these investigations
  • Address unexpected issues that arise
  • Act as a Subject Matter Exerpert in the QC lab to troubleshoot routine and non-routine methods, OOS investigations and lab equipment operation while serving as a resource of technical knowledge for established assays
  • Prepares and conducts training sessions for analytical methods, protocols and procedures
  • Establishes systems to monitor method performance over time and addresses complex problems
  • Assesses new analytical technologies for application and adoption at the sites
9

Responsibilities For Lead Specialist, Quality Control Resume

  • Leads laboratory investigations and provides governance on the content of investigation reports
  • Assess the compliance status of current test methods and equipment and benchmarks against industry practice
  • Conduct method verification, qualification and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems and developing approaches to rectify those problems
  • Develop and execute an Equipment Qualification Program to insure compliance throughout the equipement lifecycle
  • Provide expertise and oversight of Data Integrity Standards in accordance with Regulatory and Emergent Global Standards
10

Responsibilities For Specialist, Quality Control Editor Resume

  • Performs analytical evaluation or test of products or processes
  • Coordinate routine chemical and biological clearance projects for new and modified products including workflow and documentation, i.e. Technical Service Requests – Coordinate laboratory testing, experiment, or task with minimal supervision. Understands underlying test theory of standard test equipment and tests performed in lab
  • Manage Technical Service Request (TSR) System utilizing Microsoft Access to assign, track, and record completion dates of TSR projects numbers
  • Assist with development and set up of new non-standard tests and coordinate test with some supervision
  • Conduct/coordinate special projects in support of product claims; for example, chemical and chemotherapy drug permeation testing for gloves, stability/shelf-life testing, efficacy studies, cleaning validations, etc
  • Participate in determining CAH material and product test requirements which comply with applicable biosafety standards

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