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.
Chemist II should have hands-on the water by KF, Dissolution, UV (Lab solution), HPLC (Empower3) and performs routine analysis of Stability under the supervision of Quality control Group leader/manager. Testing of Stability product includes testing of related compounds, Potency assay, and Dissolution as per written procedures. Participate in investigations and write and review (Events, LDN, RMF, OOS). Knowledge of instrument Calibration and qualification (IQ, OQ, PQ). Chemists must maintain organization and meet compliance under cGMP while working under a fast-paced environment to meet priority deadlines.
• This position has no direct reports.
• In a team environment, perform duties which includes but not limited to assisting work, disciplines, coaching, training to Quality control stability employees.
• 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 Stability testing products. 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 (Atomic Absorption spectrophotometer, UV spectrophotometer, pH ,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:
• 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.
• Writing skills of LDN and OOS.
• 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 waters Empower, and Lab solutions, etc.
• Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure the 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 Teamwork
3. 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.
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.
|Job Category||Quality Control|