Purpose:
The primary function is to support the Quality Control Laboratories with independent, effective and timely testing services and able to ensure that tasks are performed according to requirements with review/verification of results and problem solving for issues identified.
Major Responsibilities:
- 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 6S 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
Qualifications
- 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 - 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
