Has knowledge of commonly used concepts, practices, and procedures within the pharmaceutical field. Follow instructions and pre-established guidelines to perform the functions of the job. Works under minimal supervision
Essential Job Function:
Under the direction of laboratory management, this individual:
- Performs review/audit of lab notebooks, analytical data, and analytical reports. Possess a demonstrated ability to write scientific reports.
- Demonstrates a thorough knowledge of approved SOP’s, compendia, ICH, FDA and other regulatory guidelines.
- Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of senior staff or laboratory management.
- Performs testing of API, Finished Product, process validation samples, cleaning validation samples, and stability samples using a variety of standard & advanced analytical techniques.
- Assists in conducting analytical method validation and method transfer activities as directed.
- Assists in preparing technical documentation including test reports, analytical test procedures, and change controls.
- Supports systems to ensure the successful completion of departmental goals and objectives.
- Has exposure to the basic theory and operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
- Has the initiative/drive to participate in a leadership capacity in one or more of several laboratory committees (e.g. Safety, Instrumentation, GMP, SOP, etc.)
- Performs all job responsibilities in a safe and efficient manner.
- Performs other duties as assigned.
- The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to stand, stoop, kneel, and crouch. Specific vision abilities required of this job include close vision, distance vision, color vision, and the ability to adjust focus.
- The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds or more.
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