QC Analyst (Chemistry + Micro) I

Quality Control Technician
12-month Contract
On-site in Clayton, NC

Overview

Perform and review analysis of in-process, release, and stability samples of API and/or filled product in accordance with cGMP, site, and corporate procedures and policies. Support transfer of technology and processes in alignment with project plans and timelines.

Requirements

• Preparation of microbiological media
• Washing and sterilization of equipment and media using autoclaves
• Reading and interpretation of environmental monitoring samples
• Bioburden testing of utilities samples via membrane filtration
• Ensure accuracy and scientific soundness of laboratory data
• Ensure environmental compliance
• Support and ensure GMP laboratory compliance
• Maintain testing proficiency for methods
• Ensure timeliness of laboratory results and investigations
• Perform analysis of samples and support deviations
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• Associate’s degree in science or relevant field of study from an accredited university required
• Bachelor’s degree in science or relevant field of study from an accredited university preferred
• One (1) year of work experience in a clinical or industrial/pharmaceutical laboratory preferred
• Ability to author scientific and technical reports is a plus
• Able to perform routine testing per SOP and GMP standards preferred
• Basic troubleshooting skills for laboratory equipment is a plus
• Knowledge of GMP and laboratory techniques is a plus
• Demonstrated attention to detail required
• Strong verbal and written communication skills preferred
• Skills or knowledge in one of the following disciplines is a plus:
  • Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, pH, KF)
  • Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin Testing, Growth Promotion, Microbial Identification, ELISA, Bioburden)
  • Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration, UVVis)

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to perform close precision work with hands
• Must be able to remain in a stationary position (sitting and standing) 50% of the time
• Occasionally ascends/descends a ladder
• May be required to work at elevated heights
• Occasionally works around odorous and/or hazardous materials
• Vision screening not required
• Color vision not required