Senior Quality Control Laboratory Analyst (Biologics) - #1115844

Job Description

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 Bio 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 product

• 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 Biologics Lab (coupled with experience in Bioassay/ Microplate/ ELISA/ HCP)

• At least 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