1. In a team environment, performs routine raw material testing under cGMP guidelines.
2. Maintains laboratory documentation with details of test procedures, raw data, and final results in accordance with regulatory guidelines.
3. Performs calibrations, standardization’s, and routine maintenance of instrumentation as needed.
4. Performs troubleshooting and initial investigative work related to out-of-specification lab results with input from senior chemists and supervisors. Conducts formal investigative procedures and aids other chemists in resolving method and instrument problems.
5. Working knowledge in calibration of Laboratory equipment used for chromatographic testing (HPLC/GC) and other laboratory analytical equipment (UV spectrophotometer, pH and conductivity meter, analytical balances, Moisture analyzer, Hardness tester, Friabilator etc). Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
6. Manages routine testing support for QC samples (Dissolution/HPLC/GC/Physical testing), Conducts laboratory disposition of materials (waste/expired chemicals) under cGMP guidelines.
7. Ensuring that laboratory documentation complies with regulatory guidelines. Responds to out-of-specification test results in accordance with regulatory guidelines and quickly isolates material issues from testing issues.
8. Organizes workflow within the team framework to ensure high throughput and quick response to production priorities.
9. Performs other tests including Process Validation Sample, Content Uniformity and QA, and all other analytical work in Wet Lab.
10. All other job related duties.
Specialized Skills and Knowledge:
1. Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: Primarily High Performance Liquid Chromatography (HPLC), UV/Vis spectrophotometer, TLC, pH meters, analytical balances including but not limited to moistures, hardness, and friability.
2. Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
3. Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result.
4. Computer skills for operation of laboratory equipment and for data processing/storage.
5. Has the ability to understand and follow written methodologies in accordance with CGMP standards. Understands and applies USP general chapters.
List the three (3) most important competencies required:
1. Verbal and written Communication/Job Knowledge
2. Planning, Coordination, Initiative and Team work
3. Ability to work on laboratory investigations initiations like Event, LDN, OOT and RMF
Minimum BS in Chemistry or science related field with 5-8 years of experience in science regulated discipline. Wet chemistry, dissolution, HPLC/GC Chromatography functional knowledge is preferred.
• 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
Avet is proud to be an Equal Opportunity Employer.
|Job Category||Quality Control|