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Quality Compliance Specialist (Validations) Position Available
Celavie Biosciences, LLC is seeking a Quality Compliance Specialist to ensure Product and System Quality.
Responsibilities will include:
Maintain GMP equipment validation status by scheduling the validations in a timely manner.
Proactively coordinate with external vendors to meet the project timelines.
Author, review and approve Equipment Validation Protocols and Reports.
Perform GMP Equipment Validations and ensure proper execution of the GMP Equipment Validations by external vendors. Ensure the precise documentation of the Validation documents.
Subject Matter Expert for the Validations and relevant Quality procedures during Audits.
Conduct Modular Cell Culture Isolator requalification activities as per the schedule and must meet the project timelines.
Schedule the Calibration and Preventive Maintenance activities for all the GMP equipment in a timely manner to maintain the equipment in a proper working and calibrated condition.
Must update and document the calibration, preventive maintenance and validation schedules for all equipment.
Must perform the Aseptic Process Simulation runs annually to ensure the Production Process Quality, including protocol and summary report generation.
Must support Cell Therapy Manufacturing during the production runs and must have a good understanding of the production process.
Knowledge of working with Wave Bioreactor system will be a plus.
Develop a Quality System in the facility pertaining to Training, Document Control, Raw Material Management, QA for Manufacturing, and QA for QC.
Must be a self-starter and must initiate the proper Quality Compliance of the new Manufacturing facility.
Must design Analytical Test Method Validations for the QC.
Submit the updates to the supervisor on a weekly basis.
Attend weekly meetings with direct supervisor and other lab members.
Must have basic Cell Culture, Aseptic Technique, Flow Cytometer, Microplate Reader and qPCR understanding for conducting the Production, Media Fill and Validation activities.
Must have experience in Quality Management System including but not limited to Change Controls, Deviations and Investigations, CAPA, Non-conformances, Risk Management, etc.
Maintain electronic notebooks and inventory logs
Data entry and basic statistical analysis
Must be proficient in authoring SOPs, Protocols, Reports
Must have familiarity with FDA guidelines for Cell and Gene Therapy, ICH guidelines for the Quality Management Systems and Analytical Test Method Validations, and ISPE guidelines for Equipment Commissioning and Qualification.
Education, experience requirements:
Bachelor of Science Degree in related discipline, with 12+ years of relevant professional experience in Pharmaceutical or Biotech Industry, or:
Masters of Science in related discipline with 6+ years of professional experience in Pharmaceutical or Biotech Industry.
Skill requirements:
Equipment Validation skills are required
Working knowledge with Isolator systems is required and must be proficient in Isolator (Modular Cell Culture Isolator) systems and related technology for the Controlled GMP production operations.
Must have experience conducting Aseptic Process Simulation
Must be proficient in communicating with external vendors
Ability to write SOPs, qualification protocols and reports
Ability to work independently
Proficient data management and analysis
Working knowledge of Microsoft Word, Excel and PowerPoint
Must be able to work in a small team environment
Must have good oral and written communication skills
Must be able to work full time and flexible hours with occasional weekend and holiday rotations
Must have an understanding of regulatory/compliance issues related to product quality, manufacturing, and cell processing facilities
Please do not apply if you require sponsorship for a work visa.
Applicants will be required to undergo background and drug screening tests.
Please no phone calls.
