Quality Assurance Scientist

2 weeks ago

Deerfield Beach, Florida, United States Pherros Biosciences Full time

Overview

At Pherros Biosciences, we prioritize quality and safety in all our endeavors. Our commitment to excellence drives our daily operations, ensuring that we produce safe and effective products. Our innovative quality culture is deeply rooted in science and risk management, aimed at enhancing healthcare outcomes. Every role, whether in development, operations, compliance, or analysis, plays a crucial part in our collective success.

Your Contribution to Our Mission

As a member of our dedicated quality control operations team, you will be integral to our aseptic manufacturing facility for parenteral pharmaceuticals. This role offers a unique opportunity to engage with a cutting-edge facility and a robust quality system. The Quality Control Laboratory is pivotal in assuring global patients of the safety, efficacy, and integrity of our drug products. We consistently exceed quality standards through meticulous execution of process, environmental, supply, and product testing.

Key Responsibilities

The Quality Control Scientist is responsible for conducting precise and timely testing of both routine and non-routine samples in alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and safety protocols. Your duties will encompass a variety of laboratory testing techniques, including but not limited to:

  • Bioburden Analysis
  • Endotoxin Testing
  • Sterility Testing
  • Growth Promotion Studies
  • Particulate Matter Analysis
  • Container Closure Integrity Testing (CCIT)
  • Microbial Identification
  • Aseptic Process Simulation (APS)
  • Visual Inspection

Additionally, you will train Environmental Monitoring (EM) Technicians and oversee EM results. Your role will involve reviewing and interpreting results, performing second person verification (SPV) of analytical data, and utilizing your technical expertise to identify continuous improvement opportunities. Other essential responsibilities include:

  • Accurate recording of data in reports or Laboratory Information Management System (LIMS) in accordance with laboratory procedures.
  • Initiating investigations for any deviations from established procedures.
  • Verifying analytical data generated by fellow analysts.
  • Adhering to all Environmental, Health, and Safety (EH&S) standards.
  • Identifying and communicating improvement initiatives in daily operations.
  • Troubleshooting laboratory equipment and methodologies as necessary.
  • Maintaining inventory of laboratory supplies and consumables.
  • Participating in training exercises to meet compliance requirements.

Qualifications

The ideal candidate will possess a Bachelor’s degree (or higher) in Microbiology, Biochemistry, or Biology, along with three to five years of relevant experience in a GMP Microbiology Lab environment. Essential qualifications include:

  • Proficiency in microbiological testing and aseptic processing.
  • Familiarity with microbiology laboratory instrumentation and environmental monitoring.
  • Strong organizational, record-keeping, and time management skills.
  • Excellent written and verbal communication abilities.

Preferred Experience

Additional preferences include:

  • Experience with a Laboratory Information Management System (LIMS).
  • Familiarity with Quality Management Systems (QMS) such as Master Control.
  • Experience in performing various microbiological tests and analyses.
  • Demonstrated problem-solving and analytical thinking capabilities.
  • Understanding of statistical tools and methodologies.
  • Strong attention to detail and ability to prioritize multiple tasks.

Work Environment

This is a full-time, non-remote position, with a Monday through Friday schedule and occasional weekend support as needed. The role may involve exposure to allergens, and tasks may require repetitive motions.

Commitment to Diversity

Pherros Biosciences is dedicated to equal opportunity in employment for all individuals, regardless of race, color, religion, sex, sexual orientation, age, gender identity, national origin, disability, or veteran status. We comply with all applicable laws governing nondiscrimination in employment.

About Pherros Biosciences

At Pherros Biosciences, we believe in our potential to enhance future healthcare and transform lives. We seek talented individuals to join our global community in delivering innovative therapies and fostering a healthier world.

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