Quality Assurance Specialist

4 days ago


Lexington, Kentucky, United States LanceSoft Full time
Job Summary

This role is responsible for the daily lab operations and execution of testing to support manufacturing operations/validation/or development studies.

The primary duties of this position will focus on testing samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols.

Additionally, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

Key Responsibilities
  • Execute testing to support manufacturing operations/validation/or development studies
  • Participate in training analysts, trouble shooting of methods
  • QC operations support, including data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups
  • Compliance and quality systems, including SOP revisions, input to quality systems records
  • Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Requirements

This position requires a bachelor's degree and a minimum of 5+ years of related experience. (Science related degree is preferred)

Excellent communication, interpersonal and organizational skills are essential for this role. Ability to work well both independently and in a team environment, prioritize work and multitask are also required.

Previous experience in a GMP QC role is preferred.

Working Conditions

This role is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.

Individual may be required to participate in environmental chamber monitoring program which would include the use of an on call mobile phone as well as on site support during non business hours.



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