Quality Control Chemist
SUMMARY: The individual performs chemical laboratory tests on pharmaceutical raw materials, components, component raw materials, in-process, finished products, and stability samples
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned) The Chemist will complete routine assignments and assist as needed on special projects and NCR investigations.
The Chemist will:
- Perform, record and report the results of chemical tests for raw materials, components, process supplies, in process, and finished products as appropriate.
- Perform, record and report the results of chemical tests for stability lots per the stability testing protocol.
- Maintain compliance with regulatory and GMP standards by performing job functions in accordance with SOPs and LTMS.
- Perform investigation of test results falling outside specifications as directed.
- The chemist will help in other tasks contributing to the overall operation of the laboratory (as assigned under QC Housekeeping) as designated by the Department Head or Department Supervisor.
REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: Bachelor's Degree in Chemistry or relevant scientific degree from a four-year college or university. Work experience in performing various wet chemistry tests is preferred. Experience and/or familiarity in the use of pH meters, balances, HPLC, GC, FTIR, and UVNIS is preferred.
LANGUAGE SKILLS: Have the ability to accurately record experimental information. Ability to effectively communicate verbally.
- Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume.
- Ability to apply concepts of basic algebra and geometry.
- Knowledge of computer on spreadsheets and word process is preferred.
- Ability to perform basic and advanced mathematical operations used in chemical analysis calculations.
- Familiarity with mathematical concepts such as probability and statistical inference preferred.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
PHYSICAL DEMANDS: 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.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, and use hands to handle or feel objects, tools, or controls; reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee frequently is required to talk and listen.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. The employee may occasionally have to work overtime or on the weekends.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee usually works in a laboratory environment, regularly exposed to hazardous chemical. The employee must occasionally work near moving mechanical parts and is occasionally exposed to wet, humid conditions, extreme heat and toxic or caustic chemicals. The noise level in the work environment is usually quiet.
Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.
EEO & Employment Eligibility
Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer.
Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.