QC Chemist I

Position Summary

Duties and Responsibilities

• Work as part of a cross-functional team to perform QC activities for technology transfer of manufacturing and testing processes to external CMO/CTOs
• Perform release and stability testing for starting materials and drug product
• Perform data review, analysis, identification of trends, and complex problem solving
• Perform assay troubleshooting and identify and implement improvements to existing assays
• Write and review QC SOPs and qualification/validation protocols and reports, as needed
• Prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS
• Ensure all products are QC tested in a timely fashion to meet customer demand
• Ensure Standard Operating Procedures are in place for all testing procedures and supporting procedures
• Ensure lab is properly equipped and supplied
• Identify and implement process/procedural improvements related to QC functions to improve efficiencies and effectiveness
• Collect and prepare data for metric reporting to management, such as Key Quality Indicators (KQI)
• Maintain control and confidentiality of documents and information 
• Ability to work unscheduled and overtime hours as needed
• Other duties as assigned

Regulatory Responsibilities  

• Ensure testing is in compliance with all applicable Regulatory requirements 
• Ensure accurate and timely date submission for Regulatory Authority
• To meet Regulatory requirements and standards set internally and those by Corporate Global Quality
• Responsible for the compliance to USDA rules and regulations and to internal standards
• Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable

Supervisory Responsibilities

Experience

Education

Knowledge, Skills & Abilities

• Experience in analytical chemistry and familiarity with Quality Control functions 
• Experience related to Quality Assurance/Quality Systems with exposure to GMP environment
• Experience with technology transfer
• Strong technical knowledge and skill base. Experience with wet chemistry and analytical chemistry. 
• Leadership skills and demonstrated ability to work in a productive and collaborative cross-functional manner
• Knowledge of cGMP/ICH/FDA/EU regulations
• Proficiency in Microsoft Office Suite applications of intermediate to advanced level 
• Superb written and oral communication skills
• “Do-what-it-takes” attitude
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Satisfactory audio-visual acuity
• Ability to read and write English
• Able to travel to customers and/or other contractual facilities as needed.

Physical Requirements 

• Ability to sit for prolonged periods of time
• Ability to stand for prolonged periods of time
• Ability to lift up to 10lbs