Quality Control Analyst

Real Staffing; Summit (NJ); On-site; USD 65,000 - 85,000; Full time

Job summary

A pharmaceutical staffing agency is looking for a Laboratory Analyst in Summit, New Jersey. This role involves conducting laboratory analysis for clinical release and stability testing. Candidates must possess a BS/MS in analytical chemistry or a relevant discipline, along with 2 to 4 years of recent cGMP pharmaceutical laboratory experience. Proficiency in HPLC, UPLC, and other analytical techniques is essential. Strong communication skills and the ability to work well in a team are also required. Compliance with cGMP documentation practices is imperative.

Qualifications

• Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
• Experience with HPLC, UPLC, dissolution, and other analytical techniques.
• Good laboratory documentation skills following cGMP.

Responsibilities

• Assist with laboratory analysis for clinical release and stability testing.
• Conduct reference standards qualification analyses.
• Perform laboratory analysis under guidance.

Skills

HPLC

UPLC

GC analysis

Dissolution testing

Karl Fischer

UV/Vis

Good communication skills

Teamwork

Education

BS/MS in analytical chemistry or relevant discipline

Tools

FT-IR

UV/Vis spectrophotometry

Job description

Responsible for assisting with laboratory analysis for clinical release and clinical stability testing. Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for NDA submissions. Participate in validation, clinical testing and technical transfer analysis. Perform laboratory analysis under guidance of a supervisor or designee. Responsibilities will include, but are not limited to, the following: Clinical release and stability testing, method validation support, reference standards qualification. Able to conduct testing independently and may assist other analysts in analytical testing including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing. Conducts routine analytical experiments using analytical methods and procedures such as finished products and API Assay, Related impurities and Dissolution testing. Draws basic conclusions from data and results and communicates with other analysts and management. Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing). Performs testing for development, release and stability samples in accordance with established methods, specifications and protocols with limited supervision. Good laboratory documentation skills. Strictly following cGMP in reference to testing and documentation requirements. Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with cGMP requirements.

Qualifications

BS/MS in analytical chemistry or relevant discipline with equivalent experience. Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience. Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc. Good communication skills. Able to work well in team environment to achieve results. Exhibits sound scientific judgment based on reasonable assumptions and available information.

Additional Information

All your information will be kept confidential according to EEO guidelines.