Chenega Corporation Researcher I-FDA/DPA-CPTS in St. Louis, Missouri
CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC
Company Job Title: Researcher I – FDA/DPA - CPTS
Chenega Job Title: Research Associate III
Clearance: Public Trust
Location: St. Louis, MO
Reports To: Program Manager
FLSA Status: Exempt, Full Time, Regular, Salary
Prepared Date: 01-13-2020
Approved Date: 01-13-2020
Chenega Professional and Technical Services, LLC (CPTS) is seeking a Researcher I to support the FDA’s Office of Pharmaceutical Quality (OPQ), Division of Pharmaceutical Analysis (DPA). The mission of OPQ is to assure that quality medicines are available to the American public. To better accomplish that mission the agency must understand the supply chain for pharmaceuticals and how to deploy and evaluate rapid testing instrumentation and methods. DPA is deploying spectroscopic methods in collaboration with the India office of the US FDA and will need a researcher to develop, assess, and deploy these methods. The Researcher I will work with DPA on deploying and evaluating rapid, non-destructive testing methods.
Duties and Responsibilities: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
Work at DPA to develop methods for spectroscopic instrumentation including Raman, near infrared and terahertz spectroscopy.
Use methods developed at DPA for these instruments to test products obtained from India that are destined for US supply chain.
Survey the quality of drugs and drug ingredients in India with the help of collaboration of the India office to help assess the quality of the supply chain.
Build spectroscopic libraries using India sourced materials.
Document the studies and report to management according to the quality management procedures in the laboratory. This may include development of work instructions, standard operating procedures, technical reports, study protocols, and presentations.
Train FDA chemists and investigators on the value and capabilities of rapid testing methods.
Other duties as assigned.
Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
- Minimum of a Bachelor’s degree in chemistry or related field and experience in all areas of spectroscopy. Experience in vibrational spectroscopy and chemometrics is a plus.
Knowledge, Skills and Abilities:
A strong background in written and oral communication with experience publishing in peer reviewed journals and independent research is desired.
Experience reviewing scientific literature and writing scientific papers.
Skill in analyzing and defining significant obstacles to program accomplishments.
Ability to independently plan, develop, and evaluate written plans.
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 and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.
Work Environment: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.)
The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.
During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.
Chenega Corporation and family of companies is an EOE.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program.
Primary Location: United States-Missouri-St. Louis
Organization: Chenega Professional %26 Technical Services
Strategic Business Unit: Professional Services
Security Requirements: Public Trust
Job Schedule: Full Time Exempt
Recruiter: Anne Goldberg
Req ID: 2000000113
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