Job Description :

• Perform stability sample pulls using GLIMS and delivery to the laboratory, adhering to GMP processes and procedures.
• Perform receipt of stability samples from production units.
• Perform shipment of stability samples to external testing laboratories.
• Perform build and setup of stability studies in GLIMS.
• Able to clearly represent individual status / accomplishments.
• Actively promotes an inclusive culture.
• Properly documents, investigates, and identifies proactive measures to ensure right first-time achievements.
• Understand and apply Data Integrity concepts.

Responsibilities :

• Perform stability sample pulls using GLIMS and delivery to the laboratory, adhering to GMP processes and procedures.
• Perform receipt of stability samples from production units.
• Perform shipment of stability samples to external testing laboratories.
• Perform build and setup of stability studies in GLIMS.
• Able to clearly represent individual status / accomplishments.
• Actively promotes an inclusive culture.
• Properly documents, investigates, and identifies proactive measures to ensure right first-time achievements.
• Understand and apply Data Integrity concepts.

• Bachelor’s degree in Science, Chemistry, Biochemistry, Biology, or related science field. Required Experience and Skills :
• Minimum of one (1) year of experience in Laboratory GMP regulated environment.
• Two (2) plus years in a pharmaceutical manufacturing and cGMP environment
• GLIMS experience
• Technical communication (written & presentation) skills. A successful candidate will exhibit : -
• Understanding of the fundamental business drivers for the company and apply this knowledge in their own work.
• Ability to interpret Company Quality Policies and Guidelines for daily application.
• Understanding and active application of regulatory / compliance requirements, including GMP and related regulations, and ability to interpret those regulations for implementation in the workplace.
• A knowledge of theories, processes, and procedures in the Quality Laboratory.
• Strong technical writing capabilities. NOTE : This is a 100% onsite role. Candidate should be flexible to come in earlier if needed.

Positions available : 2

Last updated : 2024-05-17