Quality Control Analyst I

Essential Functions

• Performs routine analytical analysis using volumetric glassware, balances, pH Meter, Conductometer, Karl Fischer (KF), TOC, Turbidimeter, GC (FID/MS), Atomic Absorption (AA), and others as required.
• Responsible for QC data analysis and data entry, using both electronic systems and hard copy documentation following GDP.
• Able to effectively communicate with cross-functional teams, including production, quality assurance, and planning.
• Reports OOS results to QC Manager or designee and assists with compiling required information to complete the investigation report.
• Performs daily and monthly analytical equipment verification and maintenance.
• Flexibility to handle unexpected situations and make adjustments to ensure compliance with 820 GMP and ISO 13485 standards.
• Assists on the review and revision of procedures and test methods.
• Assists on laboratory inventory maintenance.
• Maintains a safe, clean, and organized environment (5S) for all QC areas.
• Supports process improvements within the QC laboratory.

Qualifications

• Bachelor’s degree in chemistry or related science field required.
• At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred.
• Experience with quality control GMP documentation of analytical testing results and assurance of laboratory data integrity and compliance preferred.
• Knowledge of analytical equipment, analytical methods, and data analysis required.
• Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) preferred.
• Experience with Open Lab, Chem Station and/or Empower analytical software preferred.
• Proficiency with Adobe, Microsoft Word and Excel required.