Position Title: Finished Product Chemist I
Functional Area and Department: Quality Control
Reports to (Title): Supervisor Quality Control
1. In a team environment, performs routine raw material, In Process, Finished Product testing under cGMP guidelines. 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.
2. Performs troubleshooting and initial investigative work related to Laboratory Deviations, 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.
3. Organizes workflow within the team framework to ensure high throughput and
Quick response to production priorities.
4. Perform other tests including Process Validation Sample, Analytical Method transfer,
Cleaning Validation, Sampling, and all other analytical work in Quality Control Lab.
5. 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: Primarily High Performance Liquid Chromatography (HPLC), UV/Vis spectrophotometer, FTIR, Dissolution testing, TLC, pH meters, analytical balances including but not limited to moistures, hardness, and friability.
- Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
- Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result.
- Computer skills for operation of laboratory equipment and for data processing/storage.
- 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 (refer to attachment competency list):
1. Communication/Job Knowledge
2. Customer/Quality Focus
- Education/Certifications: Applicants must hold a Bachelor’s degree in Chemistry with Five (5) or more years of direct experience in Pharmaceutical Quality Control/Analytical Development laboratory supporting a manufacturing organization.
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.
|Job Category||Quality Control|