QC Methods Chemist I

Position Summary

Perform all activities associated with Quality Control release testing for starting materials and drug product disposition. Provide the organization with technical expertise in analytical instrumentation and chemistry laboratory experiment design. Utilize your experience with technology transfer and a knowledge of cGMP/ICH/FDA/EU regulations

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 
• 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

• Provide leadership in daily operations and have employees incorporate compliance practices into their daily routines

Experience

• Two to four (2-4) years experience in QC GMP environment, or related education

Education

• Bachelor’s degree in a Biological or related sciences

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