Senior Quality Control Analyst

4 weeks ago


Lexington, United States Tek Support Full time

The Senior Quality Control Analyst will be responsible for supporting daily lab operations and executing testing activities to support manufacturing, validation, or development studies. The individual will perform a variety of assays using approved or QC technical protocols, ensuring compliance with GMP standards and operational readiness.


Key Responsibilities

  1. Testing & Analysis: Conduct testing on samples from drug substance and drug product manufacturing, stability studies, and various protocol studies using methods such as SDS-PAGE, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmolarity, A280, etc.
  2. Quality Control: Maintain GMP readiness of QC areas and ensure operational excellence by adhering to quality standards and protocols.
  3. Reagent & Inventory Management: Manage and maintain critical reagent inventory, such as antibodies and cell banks, ensuring availability for testing requirements.
  4. Documentation: Accurately document test results, and manage sample tracking and data entry into LIMS and other systems, maintaining compliance and data integrity.
  5. Problem Solving: Address testing challenges by applying critical thinking and troubleshooting skills to ensure accurate and reliable test outcomes.
  6. Compliance & Reporting: Ensure all testing and documentation activities comply with internal policies, SOPs, and external regulatory standards (e.g., FDA).
  7. Project Participation: Engage in more complex projects and operational excellence initiatives with minimal supervision, providing support for continuous improvement.
  8. Quality Systems Management: Participate in quality systems activities using tools like SAP and Trackwise for investigations, CAPA, and change controls.
  9. Sampling & Protocol Support: Assist in sampling activities as needed and provide support in the development and review of QC technical protocols.
  10. Policy Recommendations: Propose changes to policies and procedures that affect subordinate organizations to optimize QC operations and compliance.


Qualifications

  • Education: Bachelor’s degree in a science-related field is preferred.
  • Experience: Minimum of 5+ years of related experience in Quality Control.
  • Technical Skills: Proficiency in MS Office, LIMS, SAP, and Trackwise.
  • Analytical Techniques: Hands-on experience with SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmolarity, and other analytical techniques.
  • Problem-Solving Skills: Strong analytical skills with the ability to solve complex problems.
  • Compliance Knowledge: Full understanding of GMP and industry practices.



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