Quality Control Analyst I

Job Responsibilities:

• Experience in Labware LIMS V7 and laboratory auditing processes
• Microbiology testing experience on Environmental Samples for surface and air, Purified Water Samples, and RM/FP Microbial Limit Test following USP
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS)
• Ability to communicate effectively with excellent written and oral communication skills for scientific and/or technical ideas
• Act independently and proactively to recommend methods and procedures for problem resolution
• Self-directed with ability to organize and prioritize work
• Understand Data Integrity (ALCOA+) and laboratory documentation practices

Skills:

• Comply with all safety rules and regulations.
• Perform analysis on raw materials, finish goods, API, and control substances
• Ensures that balances are reviewed and calibrated.
• Perform peer review of laboratory testing as required.
• Responsible for Wet Chemistry testing (such as LOD, PH, titration, etc.)
• Work within a team to meet productions, validation, stability, and request deadlines.
• Participates in troubleshooting of analytical test methods and laboratory instruments.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.

Education/Experience:

• Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience
• Minimum of two years’ experience in Quality Control in CGMP pharmaceutical, biotechnology or environmental laboratory