Quality Control Analyst
This role is to perform analytical testing in a cGMP environment
This position is responsible for the following:
• Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete testing in a timely and appropriate manner.
• May maintain inventory/supplies necessary to conduct routine testing
• Performs equipment maintenance and calibrations as required.
• Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
• Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
• Investigate and write exception (e.g. deviations and OOS) documents.
• May perform other duties as assigned.
Job Qualifications and Skills:
• Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
• Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
• Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
• Experience with setting up and successfully managing cell-based assays is highly preferred.
• Education, training, or experience in cell therapy a plus.
• Proficient in MS Office, Visio, Project, and statistical software.
• Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.