QC Training Specialist

Summary:

This individual is responsible for ensuring training is understood for all laboratory personnel and independently performing routine tasks in the QCC laboratory with minimal supervision.

Essential Duties:

• Work in a safe manner in accordance with site procedures
• Work with other departments to ensure each group is aware of training requirements for laboratory personnel
• Perform or assign training for QCC personnel
• Evaluate updates to QC laboratory training modules to determine retraining level required
• Supports the development and maintenance of the laboratory training process
• Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing
• Maintain the laboratory in accordance with SOPs
• Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting
• Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports

• Understand analytical techniques and execute tasks below with minimal supervision or under the direction of a test method, standard operating procedure, or a protocol.
  • HPLC
  • UV/Vis
  • FTIR
  • GC
  • Nasal Spray testing

• Participate in method transfers
• Troubleshoot analytical procedures and recommend changes and improvements in methodology
• Prepare and present data summaries as needed
• Recommend and implement, as required, innovative approaches to problem solving
• Manage time effectively
• Mentor Chemist I and II
• Other duties as assigned

Knowledge, skills and abilities:

• Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
• Team player with well-developed interpersonal, organizational, and communication skills

• Ability to handle stressful situations
• Good method validation knowledge
• Good instrument qualification knowledge
• Understand cGMPs
• Good investigative skills for OOS, OOT and aberrant result laboratory investigations
• Excellent oral and written communication skills
• Advanced knowledge in data acquisition systems such as Empower CDS

• Bachelor’s in Chemistry or related field with at least 6 years pharmaceutical industry experience
• Qualified to work with controlled substances