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QC Chemist II (Method Validation/ Development)



Posting ID: 7332231

Full time
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QC Chemist II (Method Development/Validation)- Mooresville, NC

  • Position: QC Chemist II (Method Development/Validation)
  • Placement: Contract- Open-ended, up to 8 months
  • Location: Mooresville, NC
  • Schedule: Monday - Friday
  • Shift: 1st shift
  • Pay: $24-27/hr. Pay based upon experience
  • Summary:
    The Chemist II is primarily responsible for development, validation, verification, and transfer of analytical methods within the Quality Control Department. This includes, but is not limited to, validation protocol writing, execution, finalization of validation report, and updating any associated/applicable documents. Reports to the Senior Chemist.
  • Requirements:
    • Strong knowledge and experience testing & analyzing small molecules, raw materials, Over-The-Counter products
    • Strong knowledge and experience utilizing HPLC, GC and AA
    • Strong experience with Method Development and Validation
    • Data Analysis & Problem Solving
    • Equipment Maintenance & Trouble Shooting
    • Knowledge of Lab Safety Procedures
    • Critical Thinking and Problem Solving
    • Technical Knowledge of Principles of Chemistry, Laboratory Science and Instrumentation
    • The position requires familiarity with standard concepts, practices, and procedures within the field of chemistry
    • Good communication skills (both verbal and written) are required for notebook upkeep, the writing of SOPs and reports, and interaction with other departments and shifts
    • Individual should be comfortable working both independently and within a team environment
    • The job requires strict attention to detail and procedure, good math and computer skills, solid analytical technique, and observance of cGMPs
    • Detail oriented
    • Self-starter - able to multi-task
    • Strong leadership skills
    • Ability to train entry level laboratory technicians
    • High degree of personal integrity
    • Clear understanding of cGMP requirements
    • Good math skills
    • Good PC skills - must be able to navigate spreadsheets and database entry requirements
    • Able to work flexible hours and work overtime when required

  • Qualifications:
    • Bachelor's degree (B.S.) in Chemistry with 3+ years' experience in a cGMP/GLP laboratory OR
    • Bachelor's Degree (B.S.) with 5+ years' experience in a cGMP/GLP laboratory
    • 3 years' experience with operation, analysis, and processing (chromatography) of HPLC and GC
    • Minimum three years of experience:
      • Performing routine and non-routine analysis on raw materials, stability, and finished product samples
      • Independently troubleshooting analytical test methods and instruments
      • Experience with instrument maintenance and calibrations
    • Laboratory experience in a manufacturing facility
    • Developing methods by HPLC, UPLC, GC, and LC-MS
    • Performing method verifications and validations including protocol and report writing
    • Experience with method development and validation for cleaning limit test methods
    • Executing performance qualifications on analytical instruments

  • Responsibilities:
    • Analyze products, raw materials, and certain packaging materials using established chemical and/or physical analytical techniques.
    • Perform testing of samples generated during product development, generate data to create product specifications
    • Responsible for development and validation of analytical methods and implementation
    • Write/contribute to the content of Standard Operating Procedures, validation protocols/reports, test methods, raw material/finished product specifications and other technical documentation
    • Responsible for comprehensive recording and/or review of test results, initiation and participation in investigations, and entry of data into computer systems for tracking purposes
    • Conduct troubleshooting of analytical instruments, executes general/preventive instrument maintenance
    • Monitor current analytical methods and assist in improvements and amendments according to cGMP practices
    • Responsible for maintaining all required reagents and standards for ongoing projects
    • Adhere to cGMPs requirements
    • Review laboratory data
    • Provide second review of laboratory data
    • Facilitate investigations and reports appropriately
    • Maintain a clean, organized laboratory environment
    • Perform other duties as assigned

About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.

Contact Information

Recruiter: Kate LaMonaca


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