Avet Provides high quality generic medicines and is built around centers of manufacturing and scientific excellence to provide you with the highest level of quality, safety, Value and service in generics. We are seeking a Chemist II to performs routine analysis of finish product. Testing of finish product includes testing the strength Identification, related compounds, potency assay and content uniformity as per written procedures. Participate in investigations and writing. Knowledge of instrument qualification. The Chemist must maintain organization and meet compliance under USP regulations while working under fast-paced environment to meet priority deadlines.
- This position has no direct reports.
- 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.
- Performs QC testing for drug substances, products and equipment cleaning samples. If necessary, performs other QC activities such as involved in method transfer.
- Perform Physical testing, Perform sampling (raw materials, Cleaning validation, and micro) according to approved procedures.
- 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.
- Manages routine testing support for QC samples (Dissolution/HPLC/GC/Physical testing), Conducts laboratory disposition of materials (waste/expired chemicals) under cGMP guidelines.
- 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.
- Maintains operations-focused high throughput, quick responsive materials release testing which meet the needs of internal/external customers and Avet business goals.
- Responsible for three Quality Control laboratories including Wet Lab, Dissolution Lab, and HPLC lab.
- All other job-related duties.
Specialized Skills and Knowledge:
- BS in Chemistry or science related field with minimum of 3 years of experience. Wet chemistry, dissolution, HPLC/GC Chromatography functional knowledge is preferred.
- Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: pH meters, Analytical balances, Moisture analyzer, Hardness tester and Friabilator etc.
- Ability to operate different types of Chromatographic software related to HPLC/GC. Familiar with Chromatographic software such as Class VP, waters Empower, and EZ Chrom 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.
- Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner.
- Verbal and written Communication/Job Knowledge
- Planning, Coordination, Initiative and Teamwork
- Ability to work on laboratory investigations initiations like Event, LDN, OOT and RMF
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.
All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa, or take over sponsorship of a work visa for any applicants, at this time.
At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.
Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.
Avet is proud to be an Equal Opportunity Employer.
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.