- In a team environment, perform duties which include but not limited to assisting work, disciplines, coaching, training to Quality control employees.
- Maintains laboratory documentation with details of test procedures, raw data, and final results in accordance with regulatory guidelines.
- Perform Physical testing, Perform sampling (raw materials, Cleaning validation, and micro) according to approved procedures.
- Performs QC testing for drug substances, products and equipment cleaning samples. If necessary, performs other QC activities such as involved in method transfer.
- Working knowledge in operation of Laboratory equipment like pH and conductivity meter, analytical balances, Moisture analyzer, Hardness tester, Friabilator etc).
- Ensuring that laboratory documentation complies with regulatory guidelines.
- Responsible for Quality Control laboratories including Wet Lab, Dissolution Lab. support in sampling of raw materials, cleaning samples and sample delivery.
- All other job related duties.
Specialized Skills and Knowledge:
- Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: pH meters, Analytical balances, Hardness tester and Friabilator etc.
- Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result.
- Has the ability to understand and follow written methodologies in accordance with cGMP standards. Understands and applies USP general chapters.
- Computer skills for operation of laboratory equipment and for data processing/storage.
- Working knowledge and interpretations of cGMP.
1. Verbal and written Communication/Job Knowledge
2. Planning, Coordination, Initiative and Team work
3. Ability to work under minimum supervisions.
- Minimum High school graduate in with science related field with 0-5 years of experience in science regulated discipline. Wet chemistry, dissolution, raw material sampling, cleaning sampling 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