Quality Control Specialist

2 days ago

Deerfield Beach, Florida, United States Pherros Biosciences Full time
About the Role

Pherros Biosciences is seeking a highly skilled Quality Control Scientist to join our dedicated and highly effective quality control operations team. As a key member of our team, you will be responsible for performing accurate and timely testing of routine and non-routine samples in accordance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and safety guidelines.

Key Responsibilities
  • Perform laboratory testing techniques, including bioburden analysis, endotoxin testing, sterility testing, growth promotion, and microbial identification.
  • Review and interpret results, and perform second-person verification of analytical data.
  • Utilize technical skills to perform in-depth problem-solving, identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results.
  • Accurately record data in reports or Laboratory Information Management System (LIMS) in accordance with laboratory procedures, GLP, standards, and GMP requirements.
  • Recognize deviations from procedures, methods, etc., and initiate an investigation as required.
  • Verify analytical data generated by other analysts within the lab as required.
  • Adhere to all Environmental, Health, and Safety (EH&S) standards.
  • Identify and communicate opportunities for improvement initiatives in daily work activities.
  • Troubleshoot equipment and methods as required.
  • Provide technical support for non-routine (e.g., deviation) investigations.
  • Maintain inventory of all supplies and consumables for the laboratory.
  • Gown for activities within aseptic manufacturing suites typical of a GMP environment.
  • Engage in training exercises to fulfill compliance requirements associated with the position.
Requirements

We are seeking a candidate with a Bachelor's degree in Microbiology, Biochemistry, or Biology, and three to five years of relevant experience in a GMP Microbiology Lab environment. The ideal candidate will have knowledge of microbiological testing, experience with aseptic processing, and familiarity with microbiology laboratory instrumentation and environmental monitoring.

Preferred Qualifications
  • Experience with a LIMS system.
  • Experience with a Quality Management System (QMS) such as Master Control.
  • Experience performing bioburden, endotoxin testing, sterility, growth promotion, biological particulate matter testing, container closure integrity testing, and identification techniques.
  • Demonstrated problem-solving and analytical thinking skills.
  • Understanding of statistical tools and analysis.
  • Excellent interpersonal skills and networking skills.
  • Experience in a GMP QC Lab environment.
  • Demonstrated written and verbal communications skills.
  • Strong attention to detail.
  • Ability to organize and prioritize multiple tasks.
  • Experience with Root Cause Analysis.
  • Demonstrated ability to work both independently and as a part of a team.
About Us

Pherros Biosciences is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We believe in our ability to improve future healthcare and potential to transform millions of lives.

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