Quality Control Analysts

19-4099.01

Conduct tests to determine quality of raw materials, bulk intermediate and finished products. May conduct stability sample tests.

Occupation-Specific Information

Tasks

• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Calibrate, validate, or maintain laboratory equipment.
• Ensure that lab cleanliness and safety standards are maintained.
• Perform visual inspections of finished products.
• Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
• Compile laboratory test data and perform appropriate analyses.
• Identify and troubleshoot equipment problems.
• Write technical reports or documentation, such as deviation reports, testing protocols, and trend analyses.
• Investigate or report questionable test results.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Identify quality problems and recommend solutions.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Receive and inspect raw materials.
• Train other analysts to perform laboratory procedures and assays.
• Supply quality control data necessary for regulatory submissions.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Write or revise standard quality control operating procedures.
• Participate in internal assessments and audits as required.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Develop and qualify new testing methods.
• Coordinate testing with contract laboratories and vendors.
• Evaluate new technologies and methods to make recommendations regarding their use.

Technology Skills

• Analytical or scientific software - Laboratory information management system LIMS; LabWare LIMS; Minitab; Test automation software; The MathWorks MATLAB 🔥
• Cloud-based data access and sharing software - Microsoft SharePoint 🔥
• Content workflow software - Atlassian JIRA 🔥
• Data base management system software - Relational database management software
• Data base reporting software - SAP BusinessObjects Crystal Reports
• Data base user interface and query software - Database software; dBASE; FileMaker Pro; Microsoft Access 🔥; Microsoft SQL Server 🔥; Structured query language SQL 🔥
• Desktop communications software - Eko
• Development environment software - C 🔥; Microsoft Visual Basic 🔥; National Instruments LabVIEW
• Document management software - Adobe Acrobat 🔥
• Electronic mail software - IBM Notes; Microsoft Outlook
• Enterprise application integration software - Extensible markup language XML 🔥
• Enterprise resource planning ERP software - SAP software 🔥
• Graphics or photo imaging software - SmugMug Flickr
• Internet browser software - Microsoft Internet Explorer
• Office suite software - Microsoft Office software
• Operating system software - Microsoft Windows 🔥
• Presentation software - Microsoft PowerPoint
• Process mapping and design software - Microsoft Visio 🔥
• Program testing software - Borland SilkTest; Code profilers; Hewlett Packard LoadRunner; Hewlett Packard QuickTest Professional; IBM Rational Functional Tester; IBM Rational Robot; Micro Focus TestPartner; Microsoft Visual Studio Test Professional; Parasoft SOAtest; Selenium 🔥; SmartBear Software AutomatedQA TestComplete; Watir
• Project management software - Microsoft Project 🔥
• Spreadsheet software - Microsoft Excel ; Spreadsheet software
• Transaction server software - Microsoft Internet Information Services (IIS)
• Web platform development software - Hypertext markup language HTML 🔥; JavaScript 🔥; Microsoft ASP.NET 🔥
• Word processing software - Microsoft Word ; Word processing software

Occupational Requirements

Work Activities

• Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
• Monitoring Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
• Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
• Inspecting Equipment, Structures, or Materials - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
• Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
• Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.
• Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
• Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
• Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
• Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
• Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
• Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
• Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
• Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
• Performing General Physical Activities - Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.
• Handling and Moving Objects - Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
• Controlling Machines and Processes - Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
• Operating Vehicles, Mechanized Devices, or Equipment - Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or watercraft.
• Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
• Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment - Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.
• Repairing and Maintaining Mechanical Equipment - Servicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.
• Repairing and Maintaining Electronic Equipment - Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.
• Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
• Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
• Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
• Communicating with People Outside the Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
• Assisting and Caring for Others - Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
• Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
• Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
• Performing for or Working Directly with the Public - Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
• Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
• Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
• Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
• Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
• Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
• Providing Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
• Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
• Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
• Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Detailed Work Activities

• Test quality of materials or finished products.
• Interpret research or operational data.
• Calibrate scientific or technical equipment.
• Maintain laboratory or technical equipment.
• Inspect areas for compliance with sanitation standards.
• Evaluate quality of materials or products.
• Record research or operational data.
• Apply mathematical principles or statistical approaches to solve problems in scientific or applied fields.
• Prepare operational reports.
• Analyze test results.
• Monitor operational procedures in technical environments to ensure conformance to standards.
• Advise others on business or operational matters.
• Conduct quantitative failure analyses of operational data.
• Train personnel in technical or scientific procedures.
• Prepare information or documentation related to legal or regulatory matters.
• Develop collaborative relationships between departments or with external organizations.
• Establish standards for products, processes, or procedures.
• Conduct financial or regulatory audits.
• Determine appropriate methods for data analysis.
• Evaluate new technologies or methods.
• Verify accuracy of data.
• Develop testing routines or procedures.
• Coordinate activities with suppliers, contractors, clients, or other departments.
• Advise others on the development or use of new technologies.