Analyst II Quality Control Lab

Summary

Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.

What you'll be Doing

• Carry out chemical and physical testing of raw materials, in-process samples, finished goods, and special project/protocol samples in a timely and appropriate manner.
• Utilize laboratory instrumentation, including KF Titrator, DSC, HPLC, Particle Size Analyzer and Tensile Tester, along with computer systems to collect, record and analyze data.
• Initiate and perform laboratory investigations and develop Corrective and Preventative Action Plans (CAPAs) as required.
• Maintain data integrity and ensure compliance with company Standard Operating Procedures (SOPs) and specifications, FDA, Good Laboratory Practices (GLP), Quality Systems Regulation (QSR), and Current Good Manufacturing Practice (cGMP) regulations.
• Communicate effectively and collaborate with supervisors, peers, and cross-functional teams to support production, improve efficiency, solve problems, reduce costs and improve quality.
• Support preparation for internal and external laboratory audits as required.
• Perform equipment maintenance and calibrations as required.
• May perform other duties as assigned.

What you'll Bring

• Bachelor’s Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years’ experience.
• Basic understanding of laboratory instrumentation.
• Knowledge of cGMP manufacturing and basic chemical and biological safety procedures.
• Proficient with basic computer applications, including email, intranet, online forms, training systems, performance management tools, and self-service applications.
• Must be able to read, write, and converse in English.
• Demonstrates integrity, sound judgment, strong work ethic, intellectual honesty, dedication to quality, eagerness to learn, and drive for continuous improvement and solutions.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

Pay

The estimated base salary for this position is $96,000 - $132,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.