QC Chemist II: GMP Analytical Specialist

MedPharm; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

MedPharm in Durham, NC seeks a QC Chemist II to perform testing using HPLC, GC and various wet chemistry techniques within a GMP environment. You will ensure documentation adherence and support investigations into OOS/OOT results.

The candidate should hold a B.S. in chemistry/pharmaceutics with 4–6 years of experience, or an M.S. with 3–4 years, and be proficient with Empower, Excel, Word, and analytical instruments such as HPLC, FTIR, UV-Vis.

Qualifications

• Bachelor's degree with 4–6 years of experience in chemistry/pharmaceutics.
• MS with 3–4 years in a GMP pharmaceutical lab.
• Experience with GMP documentation and ALCOA++.
• Experience with HPLC testing and troubleshooting.
• Experience with raw materials or finished product testing.

Responsibilities

• Perform testing using HPLC, GC, titrations, and various wet chemistry techniques.
• Carry out routine laboratory work with minimal supervision.
• Performs complex analyses with moderate supervision.
• Conduct routine analytical experiments using established analytical methods and procedures.
• Data entry into reports and verify calculations and daily equipment verifications for compliance.
• Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting.
• Review and maintain laboratory notebooks.
• Ensure data collected is processed and submitted for review in a timely manner.
• Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination and report writing.
• Maintains laboratory inventory and orders materials as necessary.
• Revises existing methods, SOPs, and Work Instructions as needed.

Skills

Attention to detail

Communication skills

Good documentation practices

Education

Bachelor's degree in Chemistry/Pharmaceutics

Master's degree preferred

Tools

Empower

MS Excel

MS Word

HPLC equipment

FTIR

UV-Vis

Particle Size Analyzer

Titration Equipment

Job description

MedPharm in Durham, NC seeks a QC Chemist II to perform testing using HPLC, GC and various wet chemistry techniques within a GMP environment. You will ensure documentation adherence and support investigations into OOS/OOT results.

The candidate should hold a B.S. in chemistry/pharmaceutics with 4–6 years of experience, or an M.S. with 3–4 years, and be proficient with Empower, Excel, Word, and analytical instruments such as HPLC, FTIR, UV-Vis.