Chemist

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Job description

Job Description

SUMMARY:

The Quality Control Chemists perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis.

ESSENTIAL FUNCTIONS:

* Physical and chemical testing of raw materials.
* Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.
* Maintaining Instrument Logbooks,
* Ensuring all testing performed is properly documented in laboratory notebook
* Performing peer review of work and documentation of other analysts.
* Maintaining the work area in an orderly manner.
* Keeps current with all SOP's required to perform their job assignments.
* Reports any problems with assays or components to the QC Lab Supervisor.
* Responsible for preparing and standardizing any reagents or standard materials required for analysis.
* Reports any supply needs to the QC Lab Supervisor and Lab coordinator.
* Disposes of unused samples and laboratory waste in appropriate containers.
* Performs calibration and verification of lab instruments as applicable per current procedures.
* Cleaning of laboratory glassware.
* Other duties will be assigned as required.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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.

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:

* Knowledge of laboratories regulatory programs and objectives (cGMP, GLP, etc.).
* Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
* Resourceful and well organized.
* Advanced instrumentation skills, data processing and troubleshooting capabilities.
* Excellent verbal and written communication skills with proven prior experience.
* Must be able to work in a team environment.
* Must be detail oriented.
* Flexibility and adaptability in an ever-changing, fast paced environment is essential
* Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
* Possess strong math skills.
* Familiarity with GLP/GMP guidelines.
* Familiarity with out-of-specification (OOS) and out-of-trend (OOT) investigation.
* Experience with compendial procedures from USP/EP monographs.
* Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

Qualifications

EDUCATION AND EXPERIENCE:

* BA or BS in chemistry. Minimum two years of experience in a the lab performing chemistry related duties
* Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills are required. Familiarity with HPLC/GC analytical software.

PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:

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.

This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements include:

* Ability to hear accurately the spoken word with moderate office noise or plant noise
* Ability to apply deductive reasoning and understand complicated issues
* Ability to receive instructions and follow work rules and company policies
* Ability to follow safety and security practices
* Ability to meet deadlines and effectively deal with office stress
* Ability to accurately communicate ideas, facts and technical information