Job Description
Requirements
- 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 the 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.
Knowledge
- Mathematics— Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- Production and Processing— Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- Chemistry— Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
- English Language— Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- Clerical— Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
- Computers and Electronics— Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Skills
- Quality Control Analysis— Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
- Monitoring— Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
- Reading Comprehension— Understanding written sentences and paragraphs in work-related documents.
- Active Listening— Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
- Complex Problem Solving— Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
- Critical Thinking— Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Operation Monitoring— Watching gauges, dials, or other indicators to make sure a machine is working properly.
- Writing— Communicating effectively in writing as appropriate for the needs of the audience.
- Active Learning— Understanding the implications of new information for both current and future problem-solving and decision-making.
- Speaking— Talking to others to convey information effectively.
- Judgment and Decision Making— Considering the relative costs and benefits of potential actions to choose the most appropriate one.
- Mathematics— Using mathematics to solve problems.
- Social Perceptiveness— Being aware of others’ reactions and understanding why they react as they do.
- Systems Analysis— Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
- Systems Evaluation— Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
- Time Management— Managing one’s own time and the time of others.
- Troubleshooting— Determining causes of operating errors and deciding what to do about it.