KNOWLEDGES SKILLS AND ABILITIES
- Understanding roles of QA and QC in an organization
- Ability to think critically and creatively to identify and solve scientific problems
- Ability to multitask and organize time efficiently
- Understands use and capable of working with pipettes, balances, and other laboratory equipment
- Strong interpersonal skills and excellent oral and written communication skill a must
- Works effectively with others as part of a team
- Physical ability to lift up to 40lbs and work at the lab bench for extended periods of time
EDUCATION AND/OR EXPERIENCE
- Minimum BS Chemistry or related science
- 5+ years of experience preferred
- Experience in FDA regulated industry.
- Strong knowledge of and troubleshooting of HPLC, UPLC, and UV vis
- Effective organization and planning skills
- Efficient in troubleshooting laboratory equipment
- Knowledge of good documentation practices Knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
CERTIFICATIONS, LICENSES, AND REGISTRATIONS
PHYSICAL DEMANDS AND WORK ENVIRONMENT
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.
- Majority of time can be spent wearing protective laboratory attire (Examples of attire include: goggles, gloves, lab coat)
- Minimal exposure to physical risks, such as operating dangerous equipment or working with chemicals
- Some travel possible but not frequent
- Must be able to lift 40 pounds
- Must be able to stand for long periods of time
- Must be able to sit in front of computer for long periods of time
- Fine motor skills must be sufficient to manipulate pipettes
- Corrected vision close to 20/20 and acceptable for driving
JOB TITLE: QC Analytical Chemist
FLSA STATUS: Exempt
REPORTS TO: QC Chemistry Laboratory Manager
LOCATION: Houston, TX
The QC Analytical Chemist will perform quantitative and qualitative analysis of compounded admixed product for distribution to customers nationwide. Seeking an experienced, hands-on individual to support analytical methods development and quality control activities. He/She must have a strong initiative and desire to work in a fast paced, team-oriented, dynamic environment. The Chemist must be familiar with and knowledgeable of cGMP and 21 CFR Part 11 procedures.
Mentors less experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Development and qualification of cGMP analytical methods for lot release and stability testing of products
· Perform routine potency testing using UHPLC/UV and Ion Chromatography
· Train QC chemists
· Schedule samples for analysis
· Per procedures, maintain all documents for laboratory analysis
· Identify OOL results and follow the guidance of supervision through investigation process
· Troubleshooting instrumentation
· Peer Review of Data via other scientists
· Keeping the laboratory clean
· Write, revise, and follow Standard Operating Procedures
· Maintenance of Laboratory Notebooks, Sample Receipt Logbook, Temperature Logs, Reagent Logbooks, and Equipment logs.
· Order and maintain an inventory of controlled substances and laboratory supplies.
· Provide support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.