Collins McNicholas

QC Chemistry Supervisor: 

This role will involve supervising the QC testing of the lab and QC testing of in-process, stability and final drug products.


Responsibilities:

  • Coordinate members of R&D, Manufacturing, and Formulation to provide analytical support.
  • Supervise QC Analysts, distributes work load, and monitors progress.
  • Supervises and performs product testing where required.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
  • Responsible for all Safety and cGMP activities of associates working in Quality Control Chemistry.
  • Writes and revises control test procedures and SOPs.
  • Interacts with outside customers or functional peer groups.
  • May be responsible for maintaining a specific project.
  • Maybe involved in establishing the transfer of methodology from R&D
  • Initiates and completes CAPAs and Change Controls in accordance with site procedure
  • Maybe required to review and approve Laboratory Investigations
  • Act as area SME for Internal and External Inspections
  • Perform minimally monthly performance feedback meetings with direct reports.
  • Represent area management at leadership meetings as required
  • Escalates all performance issues to management and/or HR.

Requirements:

  • Minimum of a BA/BSc in Biology, Chemistry or related field.
  • 5+ years experience in a lab that is cGMP regulated.
  • Supervisory / people management experience in a similar environment.
  • Experience with HPLC, UPLC, UV-Spectrophotometry, Densitometry, Compendial chemistry testing techniques including pH, conductivity, appearance and osmolality
  • Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
  • Enthusiastic, results and performance driven.

For more information or to apply for this position, please call Ben Forde on 061-512270

 

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