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CSI Specialty Group

Sr. 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:

KNOWLEDGE SKILLS AND ABILITIES

  • Previous experience is required in QC lab or QC stability program in a pharmaceutical or biotech environment
  • 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
  • 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:                Sr. QC Analytical Chemist

FLSA STATUS:         Exempt

REPORTS TO:          QC Chemistry Laboratory Manager

LOCATION:               Houston, TX

 

POSITION SUMMARY

The Sr QC Analytical Chemist will perform quantitative and qualitative analysis of compounded admixed product for distribution to customers nationwide.  The successful candidate must have extensive, hands-on experience in stability programs as well as the development and validation of stability-indicating and quantitative assays in cGMP environment. Proven ability to develop highly specific analytical methods for a wide variety of small/generic compounds. Exceptional cGMP documentation skills are a must for this position. Ability to adapt to a fast pace, high through-put, dynamic environment where priorities can change rapidly. 

SUPERVISORY RESPONSIBILITIES

Mentors less experienced analysts.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensures a robust and ICH/GMP compliant Stability Program is established and maintained for all products.
  •          Development and qualification of stability indicating analytical methods for lot release and stability testing of products
  •          Provide support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.
  • Generate and execute equipment and method validations and qualifications
  • Prepare scientific reports and documents, present analytical findings and use scientific literature to solve advanced technical problems.
  • Prepare and review SOPs, test methods, scientific reports and other GMP/regulatory documentation
  • Review data generated by other analysts
  • Independently apply scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems
  • Mentors and trains junior chemist and scientist and acts as an analytical chemistry resource for other staff
  • Participate in project management activities including: creating and meeting objectives for timelines, budgets, and project goals
  • Troubleshoots analyses and equipment and performs investigations
  • Performs routine testing when required




Contact Information
CSI Specialty Group
Name: Jessica Oreste


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