Job Description

Title: Quality Control Analyst - Microbiology

Duration: 4+ Months

Work Location: Sunrise, FL 33325

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 experience in a Quality Control in CGMP pharmaceutical, biotechnology or environmental laboratory
• Experience to 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
• Acts 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

ESSENTIAL AREAS OF RESPONSIBILITY

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
• Complies 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.
• Responsible for performing additional related duties as assigned.

Education/Certification/Experience:

• Requires a Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of two years relevant progressive experience in a Quality Control Laboratory environment.
• Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Labware LIMS and/or Empower preferred experience preferred.
• Microbiology testing experience preferred.

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