Chemist level 2
The Chemist Level 2 position must be able to understand, comply, and be familiarized with company policies. The chemist must comply with CGMP, GLP, GDP and NJL safety policies. They must follow respective standard operation procedures and quality practices established by the Quality Assurance and Regulatory Affairs Departments.
This position requires the chemist to have adequate and detailed knowledge of chemistry and mathematics that will help use scientific rules and methods to solve problems and help perform variety of analysis and techniques used in the laboratory. This position also requires detailed knowledge and understanding of fundamental laboratory principles.
This position will be required to work with minimal supervision and work independently. The chemist will be required to perform basic and complex routine quality testing of raw materials, in process material, botanicals, or finished products in a timely manner as per the business needs, such as meet the turnaround time for urgent, rush and standard release testing.
This position will require to participate in providing technical and scientific support for executing, validating, and verifying analytical testing. This position also requires collaboration with cross functional teams/departments to achieve a common goal or to complete a task in the effective and efficient way. Chemist 2 should be able to exercise independent scientific judgment and may be required to participate in problem solving tasks.
Role and Responsibilities
- Perform and document routine work assigned which includes operating analytical instruments and performing wet chemistry analysis in compliance with all applicable standard operation procedures, compendial monographs, policies, and regulations.
- Abide by ALOCA (Attributable, legible, contemporaneous, original and accurate).
- Able to comply and follow CGMP/GLP laboratory practice and documentation relevant to the duties and responsibilities assigned as well as able to comply with company’s requirements and regulations.
- Record and document all observations and procedures in a concise and detailed manner in laboratory notebooks in accordance with GMP.
- Perform calibration on basic and complex instruments as needed.
- Perform basic troubleshooting and maintenance on lab instruments.
- Required to adjust workload based upon changing priorities.
- Able to adapt to changes with company’s policy’s and regulations.
- Maintain assigned instruments or assigned equipment as required/needed.
- Ensure testing and results are conducted and reporting without comprising quality and released in a timely manner to meet the deadline set, such as urgent, rush or standard turnaround time.
- Required to prepare test solutions/volumetric solutions or other solutions as needed and to standardize volumetric solutions as needed.
- Ensure all appropriate supplies and reagents are in stock for the team to use and all expired chemicals, reagents or standards are appropriately segregated. Communicate frequently with managers and QC Coordinator.
- Able to follow and comply with proper disposal of waste and environmental regulations.
- Required to maintain a safe, clean, and organized laboratory environment (i.e. keep bench areas clean, free of debris and dust, dispose chemicals properly, store samples and chemicals in appropriate places, etc.). Ensure fume hoods are maintained after use.
- If an Out of Specification (OOS) occurs, immediately notify one of the following personnel QC Manager, Technical Supervisor or Quality Assurance Team. May be required to participate in decision making of OOS investigations and execute OOS investigations as directed and needed.
- Successfully perform variety of wet chemistry testing such as titrations, pH determinations, loss on drying, residue on ignition, etc.
- Successfully operate variety of analytical instruments such as FTIR, UV-Vis, HPTLC, TOC, Nitrogen Analyzer, HPLC, ICP-MS, GC, etc.
- Required to accommodate business needs by executing time management skills and prioritizing tasks.
- Participate in training of new personnel in laboratory as assigned.
- Participate in evaluating, re-qualifying, or updating in-house developed methods, SOPs, or compendial procedures.
- Participate in method development, verification and validation testing and studies with supervision.
- Participate in team discussions and contributes with recommendations to help improve procedures.
- Able to interpret USP and compendia procedures with minimal guidance.
- Perform peer review and evaluation of data of basic and complex analytical testing of other team members based on expertise.
- Participate in all training conducted by the company.
- Effectively communicates with QC manager/supervisor on project status and problems encountered.
- Perform other related and miscellaneous duties as required.
- Inform QC manager/supervisor for any quality related issues that arise in the laboratory.
The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.
- Bachelor’s Degree in Chemistry or related discipline or 5+ years in related laboratory experience.
- Must have experience in performing wet chemistry analyses and in operating analytical instruments.
- Must have detailed knowledge of inorganic chemistry, organic chemistry, arithmetic, geometry, statistics and algebra.
- Knowledge of the structure and content of the English language including meaning and spelling of words, rules of composition, and grammar.
- Experience in problem-solving and critical thinking.
- Knowledge and familiarity of safety and waste disposal procedures in a laboratory environment.
- Computer competency with experience in Microsoft Office.
- Legible handwriting.
- Able to work independently and as a team.
- Good adaptability skills.
- Ability to perform multiple tasks simultaneously.
- Good interpersonal and communication skills (both verbal and written). Possess active listening skills.
- Ability to learn new techniques and efficiently perform complex analyses.
- Familiar with interpreting and following USP methods and procedures.
- Knowledge and familiarity of CGMP, GLP, and GDP requirements.
- Good planning and prioritization skills.
- Comfortable in fast-paced environment with ability to adjust workload based on upon changing priorities; self-motivated.
- Knowledge of FDA or ICH regulatory guidelines.
- Able to understand data integrity.
WORK CONDITIONS AND PHYSICAL REQUIREMENTS
This position must work a minimum of 40 hours a week over a period of 5 days a week and may require additional hours to meet project deadlines. This position does not require traveling.
- Wear proper protective equipment.
- Sometimes exposed to loud sounds or distracting noise levels.
- Are often exposed to contaminants or hazardous conditions while conducting analyses.
- Work within several feet of others in the laboratory.
- Sit or stand for an extended period.
- Be able to lift objects up to 25 pounds.
- May have to crawl or climb to perform certain tasks like maintenance of an instrument.
- Repetitive tasks with few breaks.
Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.