Job Title: QA/QC Specialist

Our Client is  looking for a detail-oriented and experienced QA/QC Specialist to become part of their team. This critical role ensures that our products and processes consistently meet the highest quality standards and comply with all relevant regulations.  

This role primarily focuses on the responsibilities of an experienced QC Analyst with a strong GMP background and experience working within a QMS. The successful candidate will independently perform a range of analytical and quality tasks, provide technical leadership, and drive continuous improvement initiatives.

Responsibilities 
• Conduct analytical testing, method optimization/validation, and/or other specialized technology studies or method transfers for excipients and raw materials independently
• Adhere to methods, protocols, and SOPs with precision
• Designs and executes experiments independently
• Prepares, reviews and critiques study protocols, project status reports, final study reports and other project-related documents
• Communicates data and technical issues to colleagues and upper management. Works to independently resolve technical issues
• Provides technical mentorship and training to a team of quality analysts
• Leads analytical (method related and instrumental) troubleshooting
• Plan, direct and implement improvements in systems and processes
• Preparation and implementation of SOPs, methods, and quality systems
• Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs and Good Manufacturing Practices (GMP)
• Performs self and peer review of the data for accuracy and compliance
• Initiate and lead non-conformances, change controls, CAPAs, OOS investigations, and customer complains
• Communication with vendors for tracking and scheduling IQ/OQ of instruments
• Establish and monitor key quality metrics, prepare quality reports, and present findings to senior management. Use data to drive continuous improvement initiatives
• Identify, monitor and implement compliance requirements per applicable regulatory bodies
• Provide training and mentorship to junior analysts on GMP compliance, quality assurance processes, and best practices. Foster a culture of continuous improvement and quality excellence.

In order to be qualified for this role you must possess the following:
• Minimum B.Sc Degree or equivalent, alternatively in some cases, a combination of relevant education, training, and/or directly related experience may be considered sufficient to fulfill the requirements of the role
• 4-6+ years experience that provides the knowledge and skills to perform the job
• Significant industry experience within an analytical testing laboratory, working in a QMS, and GMP environment is essential

Skills
• Technical experience and/or knowledge in a range of analytical techniques including but not exclusive to GC, ICP-MS, Karl-Fisher, potentiometric titration, GPC (size exclusion chromatography), polarimetry
• Experience in QMS activities including non-conformances, OOS investigations, root cause analysis, change controls
• Mentorship experience
• Time management and project management experience
• Technical writing skills
• Experience in 5S or lean lab culture
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff