Analyst QC Chemistry and Devices

Role Summary

A laboratory Chemistry and Device Testing Analyst performs accurate and timely testing of routine lab samples in accordance with GMP and safety guidelines to support site production and stability requirements. The Analyst conducts testing using methods such as UV-VIS, HPLC, Capillary Electrophoresis (CE), and device testing, and performs compendial analyses (e.g., pH, color, clarity, osmolality). They review and interpret results, perform second-person verification of analytical data, and use technical problem-solving to identify opportunities for continuous improvement and assist in resolving laboratory investigations of atypical data and results.

Responsibilities

• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.
• Accurately record data in reports or LIMS in accordance with laboratory procedures, standards, and GMP requirements.
• Recognize deviations from procedures and initiate investigations as required.
• Verify (SPV) analytical data generated by other analysts within the lab as required.
• Adhere to Environmental, Health, and Safety standards.
• Identify and communicate opportunities for improvement initiatives in daily work activities.
• Troubleshoot equipment and methods as required.
• Support lean lab and 5S initiatives.
• Understand the scientific principles required for testing of drug substances and drug product, including interactions of chemistry and lab equipment.
• Provide technical support for non-routine (e.g., deviation) investigations.
• Maintain inventory of all supplies and consumables for the laboratory.

Qualifications

• Required: Bachelor (4-year) degree in Chemistry, Biology or Microbiology and relevant experience in a chemistry lab.
• Preferred: Experience with a Laboratory Information Management System (LIMS) and Empower; laboratory experience with HPLC and CE instruments; demonstrated problem solving and analytical thinking skills; understanding of statistical tools and analysis; excellent interpersonal and networking skills; experience in a GMP QC lab environment; demonstrated written and verbal communications skills; strong attention to detail; ability to organize and prioritize multiple tasks; experience with lean lab and the 5S concept; experience with Root Cause Analysis; may be required to provide on-call support; ability to work independently and as part of a team.

Skills

• Analytical thinking and problem-solving
• Strong data recording and interpretation
• Attention to detail and organizational abilities
• Communication and teamwork
• Proficiency with laboratory instruments (HPLC, CE) and LIMS

Education

• Bachelor‚Äôs degree in Chemistry, Biology or Microbiology

Additional Requirements

• 10-hour days ‚Äì Wednesday through Saturday.
• May require on-call support; minimal travel.
• Mobility in various areas of the site and exposure to allergens; consider these factors when applying.
• Tasks may involve repetitive motion (e.g., keyboarding).