Perform analytical work for method validation per written procedures and cGMP Guidelines. Assist method validation department for general tasks including ordering of chemicals and HPLC accessories. As needed do routine tests for Quality Control Department. Upkeep the lab with respect to the Instruments and Apparatus.
Specialized Skills and Knowledge:
- Performs method validation and method verification/development tests under the supervision of group leader and manager and other senior chemists for drug substances and drug products.
- Assists in preparation of Protocols and reports.
- Review Method Validation Protocols / Reports and QC Methods as needed.
- In a team environment, performs routine product release testing and product stability testing under cGMP guidelines. Routine testing support for process validation, batch size increases, and operations equipment qualification. Maintains laboratory documentation with details of test procedures, raw data, and final results in accordance with regulatory guidelines. Performs calibrations, standardization’s, and routine maintenance of instrumentation as needed.
- If necessary, performs other QC activities including raw material release, stability, and process validation.
- Performs basic troubleshooting and initial investigative work related to out-of-specification lab results with input from supervisors. Organizes workflow within the team framework to ensure high throughput and quick response to production priorities.
- Can perform the duties of HPLC/GC/AA/UV and Dissolution.
- Must have a demonstrable working knowledge of Microsoft office applications
- Fundamental knowledge of Microsoft Active Directory.
- Basic knowledge to operate Laboratory Instruments and Apparatus.
- Minimum MS in Chemistry or related science field:
Minimum Bachelor degree with a science (or related field) major
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here 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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs