Job Description

Title: Quality Control Analyst I

Location: Sunrise, FL

Duration: 6 – 12 months

Shift Schedule: Monday to Friday 8am – 5 pm

Job Description:

• Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience.
• Microbiology, Biology, Biochemistry bachelor degree or similar science education.
• Minimum of two years relevant progressive experience in a Quality Control in CGMP pharmaceutical, biotechnology or environmental laboratory.
• 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.
• This position performs testing of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records.
• 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.
• 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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