Performs a variety of chemical analyses on raw materials, final products, in-process materials, or stability samples in support of the company’s quality program.
Essential Duties and Responsibilities include, but are not limited to, the following
• Gathers data and documents test results.
• Reviews test results to ensure compliance with standards; reports any quality anomalies.
• Complies with all pertinent regulatory agency requirements.
• Participates in required training activities.
• Maintains laboratory supplies.
• Conducts testing on raw materials, in-process, product, stability, and/or research samples.
• Writes and revises control test procedures and SOPs.
• Completes test records and reviews data.
• Calibrates or verifies calibration of instruments/devices prior to use.
• Interacts with outside customers or functional peer groups.
• May be responsible for maintaining a specific project.
• May devise or develop new analytical methods and techniques.
• May assist in validation of methods.
• May be involved in establishing the transfer of methodology from R&D.
• Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
• 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
Lead-Related Activities include, but are not limited to, the following
• Provides on-the-floor guidance and support to employees.
• Ensures employees timesheets are completed on time.
• Monitors employees training to ensure that all requirements are met, including OJT.
• Maintain up to date training records for self and direct reports.
• 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.
Education and Experience
• A third level qualification (BSc degree or higher) in chemistry, biology or related field. Preferably with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry
• Excellent Communication skills, both verbal & written.
• Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
• Adaptable and flexible, willing to work shift if required 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
o UV-Vis spectrophotometry
o Wet chemistry testing techniques including pH, conductivity, appearance and osmolality
• Raw Material
o FTIR, NIR spectroscopy
o Familiar with USP, JP and EP methodology