Laboratory Operations Chemist

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Primary Responsibilities

• Routine laboratory dissolution, assay/degradate, content uniformity, and identity testing and documentation in a GMP laboratory
• Entering data into Labware, participating in investigation meetings and some drafting of investigations, participating in root cause analysis, simple troubleshooting instrumentation issues, and participation in the daily tier process
• Testing equipment utilized include but are not limited to UV, HPLC, FTIR, dissolution baths, & Karl Fisher, pH meter, conductivity meter, & NIR

This is an entry level position with high expectations in a fast-paced laboratory, requires a good knowledge of GMP documentation and a good Team mindset.

Education Requirements

• Bachelor or Arts or Science degree (preferably in Science or Engineering)

Required Experience and Skills

• Knowledge of continuous improvement standards
• Two (2) or more years of experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
• Two (2) or more years of experience operating routine laboratory equipment including but not limited to: Karl Fisher, pH meter, conductivity meter, UV, etc.

Preferred Experience and Skills

• Knowledge of regulatory and cGMP principles
• Utilizing Empower
• Utilizing Labware/LIMS
• Execution of root cause analysis
• Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications
• Knowledge of Tier processes
• Executing 5S principals

#WilsonQA

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com