Job Description

POSITION SUMMARY

• This position performs testing of raw materials and drug products, maintenance, and calibration of analytical equipment instruments, prepares standard and sample solutions, and maintains appropriate records.

Core essential skill sets candidates must have to be considered for the role:

• Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience
• Minimum of two years of experience in Quality Control in CGMP pharmaceutical, biotechnology, or environmental laboratory
• Experience 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 a 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
• Acts independently and proactively recommends methods and procedures for problem resolution
• Self-directed with the ability to organize and prioritize work
• Understand Data Integrity (ALCOA+) and laboratory documentation practices

Essential Areas Of Responsibility

• All areas of responsibility listed below are essential for the satisfactory performance of this position by any
• incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Carries out responsibilities under the organization’s policies, procedures, and state, Federal, and local laws.
• Complies with all safety rules and regulations.
• Perform analysis on raw materials, finished 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 production, 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.
• Responsible for performing additional related duties as assigned.

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