Quality Control Analyst

Roles & Responsibilities

• Maintain lab supplies, reagents and standards
• Create and issue batch records
• Maintain personal laboratory work area and assist in general laboratory cleaning
• Write OOS investigations and reporting
• Affords assistance in CAPAs and Deviations
• QC data generation, review, control and retention
• Generation of product Certificates of Analysis (CoA)
• Write and execute Stability Studies
• Affords other support functions as assigned

Essential Functions/Job Duties

• Perform analytical testing and reporting in support of production, raw material and product release, product development and stability in accordance with procedural and cGMP requirements
• Laboratory instrumentation operation, system suitability checks, calibrations and maintenance

Minimum Qualifications

• Strong attention to detail and documentation practices
• Ability to read and follow written procedures
• Strong communication skills, oral and written
• Must be proficient in Microsoft Outlook (or similar) and comfortable working in Microsoft Word and Microsoft Excel
• Previous Quality experience in a regulated environment preferred
• Computer skills and use of databases for specifications
• 0-2 years of experience in in QC laboratory setting

Preferred Qualifications

• Bachelor’s degree in scientific discipline or equivalent work experience in a scientific or pharmaceutical field

Education Requirements

• Associate’s degree in scientific discipline or equivalent work experience in a scientific or pharmaceutical field

Physical Requirements

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.