1. Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
2. Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
3. Compile laboratory test data and perform appropriate analyses.
4. Write technical reports or documentation, such as deviation reports, testing protocols, and trend analyses.
5. Investigate or report questionable test results.
6. Participate in out-of-specification and failure investigations and recommend corrective actions.
7. Supply quality control data necessary for regulatory submissions.
8. Prepare or review required method transfer documentation including technical transfer protocols or reports.
9. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
10. Review data from contract laboratories to ensure accuracy and regulatory compliance

1. Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
2. Perform visual inspections of finished products.
3. Receive and inspect raw materials.

1. Calibrate, validate, or maintain laboratory equipment.
2. Identify and troubleshoot equipment problems.
3. Calibrate, validate, or maintain laboratory equipment.
4. Ensure that lab cleanliness and safety standards are maintained.

1. Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
2. Write or revise standard quality control operating procedures.
3. Develop and qualify new testing methods.
4. Evaluate analytical methods and procedures to determine how they might be improved.

1. Identify quality problems and recommend solutions.
2. Train other analysts to perform laboratory procedures and assays.
3. Serve as a technical liaison between quality control and other departments, vendors, or contractors.
4. Participate in internal assessments and audits as required.
5. Coordinate testing with contract laboratories and vendors.
6. Evaluate new technologies and methods to make recommendations regarding their use.

· Understand why the industry is governed by Good Manufacturing Practices regulations, and how those regulations drive patient and business success. · Identify risks associated with medical device, drug and human factors risks (a) design process controls to reduce risk to product quality (b) determine the correct classification of medical devices in order to design an appropriate development strategy (c) identify primary and secondary clinical trial targets to demonstrate product safety and efficacy, and (d) understand risk to product on the market related to manufacturing failures. · Describe the medical device and pharmaceutical Quality Systems, and how those systems enable organizations to consistently produce products that are of the purported quality and safety, and meet user needs. · Recognize the significance of the data and studies needed to support product-related decisions made across the total product lifecycle.

· Describe what needs to be studied and demonstrated during medical device and drug product development, from process controls, safety, efficacy, function, stability, scale-up, process validation and test method validation. · Effective ways to monitor and predict product and process performance. · Increasing right-first-time rates through enterprise-wide feedback loops to inform future product development.

· Demonstrate practical use of risk management tools, such as 5 why’s, fishbone diagram, failure mode effect analysis and surveys. · Assess a failure situation for root cause, impact to product (in production and on-market), trends, and corrective/preventative actions that will be effective at preventing recurrence. · Demonstrate the experience gained in class with writing failure investigations that are supported by data and are scientifically sound.

· Demonstrate an understanding of operating and capital expenses · Determine fixed assets and liabilities · Calculate cash flow, profit and net worth

· Apply critical thinking and quantitative reasoning to scientific data to draw conclusions and construct foundational knowledge in the life sciences · Apply the scientific method to explore, analyze and question biological phenomena · Apply core concepts in biology (Information, Evolution, Cells, Homeostasis, and Emergent Properties) to understand biological phenomena including human disease