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CSI Specialty Group

QC Analytical Chemist

Post Date:Feb 09, 2018Type:Full-Time
Start Date:2/9/2018Salary:$70,000.00
Location:US-TX-Houston Job Reference:
Skills:

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

  • None

 

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 Description:

JOB TITLE:                QC Analytical Chemist

FLSA STATUS:         Exempt

REPORTS TO:          QC Chemistry Laboratory Manager

LOCATION:               Houston, TX

 

POSITION SUMMARY

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.

SUPERVISORY RESPONSIBILITIES

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.

 

 

 





Contact Information
CSI Specialty Group
Name: Jessica Oreste


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