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.