Full Time Professional
CaseBioscience is a quality-driven cGMP manufacturer and formulator of advanced media and biopreservation solutions to serve and advance the fields of cell therapy, gene therapy and regenerative medicines. Our mission is to serve as a reliable and timely strategic partner to support research, pre-clinical and clinical activities through our custom manufacturing services and our innovative culture medium and biopreservation solutions.
General Summary and Purpose
- Write and revise standard operating procedures (SOPs) for GMP laboratory operation processes and instruments
- Ability to interview cross functional subject matter experts and translate their description into actionable instructions
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interview the supervisor/employees for information on procedures.
- Watch employees perform procedures for clarification. (Must be able to pass clean room gown qualifications.)
- Writing notes of the employees tasks.
- Typing the notes into a SOP document.
- Tracking documents in the quality system to ensure timely completion.
- Ensure verbiage is clear and concise.
- Possess the ability to analyze and resolve complex problems, making clear recommendations for solutions.
- Verifies own work and ensures the correct and timely implementation of all documentation. Checks format and compliance to company templates.
- Actively participates in an environment that fosters safety, quality and continuous improvement in cost and customer service.
- Education – BSc, MSc or PhD required preferably in a life-science related field, such as Biology, Molecular Biology, Microbiology, Immunology, Biochemistry, Biotechnology, or Engineering
- Prior experience with SOP, and or Procedure Development writing.
- Excellent written and oral communication skills with a thorough knowledge of grammar, spelling and punctuation.
- Ability to perform detailed-oriented work with a high degree of accuracy.
- Ability to explain complex concept with clarity and simplicity.
- Must possess effective organizational and time management skills with the ability to multitask and work towards multiple priorities and goals.
- Should understand and be able to apply communication theory and practices to designing, creating, editing and revising documentation.
- Must be able to work independently but be able to identify problems proactively and know when to seek advice.
CaseBioscience is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.