Responsible for the timely completion and data verification of all testing of raw material, intermediates, in-process control samples and final product
Maintain up-to-date, complete and precise records of all tests performed
Ensure that all test equipment is used and maintained properly in GMP environment
Acts as an SME for simple to complex instruments and techniques where needed
Lead and perform any method transfer or method validation protocols or equipment qualifications and support the transfer of new products
Understands, implements and maintains cGMP and 65 concept
Able to present clearly and lead confidently during audits and site leadership inquiries
Write/revises procedures as necessary and make recommendations for process improvement
Effectively perform a multitude of laboratory techniques for which they are trained on with minimal error
Trains new analysts and technicians on all instruments/techniques, as well as routinely reviewing that all API lab personnel are adhering to proper GMP standards
Responsible for assisting the lab supervisor in following up with corrective actions
Responsible for ownership of laboratory investigation - Able to lead the whole laboratory investigation and work alongside with QA for success closure of investigation
Participate in tier meeting for manufacturing updates on incoming raw materials/in-process samples and final API
Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements by driving all EHS standards, procedures and policies
About You:
Bachelor of Science majoring in Biology, Chemistry, Biochemistry or related scientific degree
At least 5 years of experience in a QC Lab
At least 1-3 years of experience in a pharmaceutical manufacturing environment
Strong GMP background and proficient with using laboratory equipment
Highly motivated, independent and able to work under pressure
Possess good interpersonal and communication skills
Strong analytical, problem solving and writing skills
Team motivator \xe2\x80\x94 able to motivate and be role model for less experienced peers
Total commitment to quality and maintaining a high standard of work at all times