21233 – QC Supervisor Chemistry – Limerick Full Time

Purpose:

Oversees the laboratory quality control testing of in-process, stability, and final drug products.

Responsibilities:

• Coordinates with members of Manufacturing, R & D, and Formulation to provide analytical support.
• Supervises 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.

Minimum Qualifications and Experience:

• A third level qualification (BSc degree or higher) in chemistry, biology or related field. MS preferred.
• Preferably with 5+ years progressive, hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.
• Relevant experience may be considered in lieu of educational requirement.
• Supervisory/leadership experience required.
• Excellent Communication skills, both verbal & written.
• Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise etc., is an advantage.
• Adaptable, flexible and willing to travel when needed.
• Collaboration and team work. Maintains the highest standards of ethical behaviour.
• Results and performance driven.
• Strong analytical ability and associated problem solving.
• Good time management and attention to detail.
• Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
• Preferred Laboratory Experience in one or more of the following areas:
  • HPLC
  • UPLC
  • UV-Vis spectrophotometry.
  • Densitometry
  • Compendial chemistry testing techniques including pH, conductivity, appearance and osmolality.