Knowledge Skills

Know how to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

Understand and comply with the procedures and systems needed to comply with company standards.

Understand project timelines, start-up and changeover schedules

Understand the meaning of a quality system and how a company's practices are used to maintain quality.

Understand quality systems and documentation

Companies that manufacture substances regulated by the FDA must adhere to Good Manufacturing Practices (GMPs). Good Documentation Practices (GDP) are important in recording and managing data related to test results.

The FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the U.Ss food supply, cosmetics, and products that emit radiation. They also regulate tobacco.

Review, document, maintain, and order laboratory supplies. Record information.

Know how to perform IQ, OQ, PQ (Installation Qualification, Operational Qualification, Performance Qualification). These are three activities that must be performed on equipment and machines as part of the validataion of manufacturing processes.

Understand and comply with environmental health and safety rules to prevent injuries, protect the environment, and prevent pollution.