QC Analyst II

2 weeks ago

Fort Worth, United States Randstad Life Sciences Full time
Job DescriptionJob Description

Immediate opportunity for a an experienced QC Analyst II (QC Chemist) with HPLC and analytical method validation experience. Compendia testing experience is a plus As a Quality Control Analyst II, you will analyze chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of compliance with company standards and governmental regulatory requirements.

Schedule/Shift: 1st shift, Mon.-Fri.

Position Type: 1 year contract position

Essential Duties and Responsibilities:

  • Ensure that lab cleanliness and safety standards are maintained.
  • Develop and qualify new testing methods.
  • Train other analysts to perform laboratory procedures and assays.
  • Perform visual inspections of finished products.
  • Participate in internal assessments and audits as required.
  • Identify and troubleshoot equipment problems.
  • Evaluate new technologies and methods to make recommendations regarding their use.
  • Serve as a technical liaison between quality control and other departments, vendors, or contractors.
  • Coordinate testing with contract laboratories and vendors.
  • Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
  • Write or revise standard quality control operating procedures.
  • Supply quality control data necessary for regulatory submissions.
  • Receive and inspect raw materials.
  • Review data from contract laboratories to ensure accuracy and regulatory compliance.
  • Prepare or review required method transfer documentation including technical transfer protocols or reports.
  • Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
  • Participate in out-of-specification and failure investigations and recommend corrective actions.
  • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
  • Investigate or report questionable test results.
  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
  • Identify quality problems and recommend solutions.
  • Evaluate analytical methods and procedures to determine how they might be improved.
  • Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
  • Calibrate, validate, or maintain laboratory equipment.
  • Compile laboratory test data and perform appropriate analyses.
  • Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

Qualifications:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
  • The ability to fluently read, write, understand, and communicate in English
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industryCompany DescriptionA great company doing groundbreaking and important work with a great reputation in the industry

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