Job Description

Responsibilities:

• 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.

• 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

• Min Degree in Biology, Chemistry, Biochemistry or related scientific degree

• Min 5 years of relevant work experience preferably in QC lab

• Prior experience using analytical instruments such as HPLC, GC and MS is preferred

• Prior Experience working in a lab in a Good Manufacturing Practice (GMP) environment