Job Description
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
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