Quality Control Analyst III
Goodwin Biotech - Plantation, FL

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QC Analyst III

Scope of Function:

Work within the Bio-analytical Chemistry group to provide analytical support, test results and qualification of analytical methods and stability studies for clients in pre clinical and clinical development. Work with process development and manufacturing groups by providing QC support to assess the purity, potency, strength and stability of in process and final vialed product. Develop and write SOP’s, qualification protocols, investigations, deviations and reports. Summarizes and interpret analytical data and present results in team meetings.

Specific Duties:
  • Understand and perform a wide range of analytical techniques including pH, protein concentration, electrophoresis, HPLC, ELISA and visual inspections.
  • Interpret experimental data to statistically summarize results and key findings.
  • Create or revise departmental SOPs.
  • Attend manufacturing meetings and other meetings as required.
  • Execute qualification and validation protocols.
  • Create, execute and compile qualification and validation protocols/reports related to Analytical
  • Investigate/troubleshoot assay problems.
  • Write deviations, investigations and OOS reports as necessary.
  • Other duties as necessary

  • Education, Experience and Skills Required:
    Education :
    BS in a scientific discipline.

    Experience :
    Must have at least five years work experience in GLP/GMP FDA regulated environment.

    Interacts With:

  • Outside contractors for certification or calibration of equipment and testing
  • All manufacturing, Process Development /Quality Assurance department.
  • Clients as needed for audits or technical information.

  • Goodwin Biotech - 9 months ago - save job