Analytical Quality Control Specialist

7 days ago

Clearwater, United States CoreRx Inc Full time
Job Summary

CoreRx Inc. is seeking a highly skilled and detail-oriented Analytical Quality Control Specialist to join our team. As an integral part of our quality control team, you will be responsible for performing raw materials and clinical and commercial pharmaceutical products testing according to compendial methods and/or methods provided by our analytical development team or clients.

Key Responsibilities
  • Perform relevant QC testing, such as HPLC, GC, Dissolution, Malvern, and wet chemistry testing as required in compliance with cGMP requirements, compendia standards, and internal procedures.
  • Ensure testing is properly conducted and documented for all performed activities with emphasis on data integrity.
  • Prepare test solutions, volumetric solutions, and samples used in analysis.
  • Perform assigned physical tests, chemical tests, and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products in an FDA-regulated lab environment.
  • Perform analysis with a practical understanding of the test procedure and instrument operation.
  • Conduct laboratory analysis right first time, contemporaneous documentation, analyze, and document the results.
  • Conducts laboratory investigation under the supervision of the laboratory manager.
  • Complies with all regulatory/in-house requirements, including but not limited to safety, housekeeping, laboratory chemical waste, cGMP, documentation.
  • Maintain required level of training needed to perform a GMP task.
  • Notify manager immediately of nonconforming data or unexpected occurrences.
  • Organize work schedule to complete assigned tasks efficiently and on schedule.
  • Work under direction provided by manager.
  • Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
  • Perform other related duties as assigned by management.
Requirements
  • Experience in UPLC/HPLC GMP operations.
  • Knowledge with analytical equipment and Part 11 compliant software, such as Chemstation, Chromeleon, EMPOWER, and Laboratory Information Management System.
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven, and highly flexible team-player in a fast-paced working environment.
  • Proficient in Microsoft Office Suite or similar software.
  • Minimum of 2 years experience preferred in an FDA-regulated pharmaceutical environment.
  • Experience in other highly regulated laboratory settings will be considered.
  • BS/BA in life science or chemistry required.
  • Equivalent experience may substitute for stated requirements.
Physical Demands
  • Regularly required to stand.
  • Frequently required to sit, walk, talk, hear, handle or feel tools or controls.
  • Occasionally required to reach with hands and arms, stoop, crouch, climb or balance, kneel.
  • Vision suitable for performing detailed inspections.
  • May be required to move items weighing up to 25 lb.
  • Ability to communicate clearly in both written and verbal form.

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