J&J Family of Companies
QA Specialist II
Janssen Supply Groups is recruiting for a QA Specialist II, located in or Raritan, NJ! This position is Tuesday to Saturday first shift 8:00AM - 4:30PM. This is an onsite position. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. As a QA Specialist II you will release incoming patient apheresis material for CAR-T treatment manufacturing. Come join our fast-paced and dynamic team to deliver this cutting-edge therapy to our patients. Key Responsibilities:
Partner with Operations teams to support production activities related Advanced Therapy products in a cGMP manufacturing facility. Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies. Participate in continuous improvement activities. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. Maintain a sufficient inventory of materials necessary for daily functions. If necessary, support adjacent QA groups with record issuance and management. Other duties may be assigned as necessary. Qualifications:
Education: A minimum of a Bachelor's Degree in a scientific field Experience and Skills:
Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required. Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems. Preferred:
Cell and Gene Therapy Experience CAR-T and/or Lentiviral vector manufacturing or QA Experience Experience and/or knowledge of Aseptic techniques Ability to learn and use various systems including eLIMS, COMET, SAT is highly desirable Other:
Tuesday - Saturday first shift 8:00AM - 4:30PM May require up to 10% domestic travel Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
Janssen Supply Groups is recruiting for a QA Specialist II, located in or Raritan, NJ! This position is Tuesday to Saturday first shift 8:00AM - 4:30PM. This is an onsite position. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. As a QA Specialist II you will release incoming patient apheresis material for CAR-T treatment manufacturing. Come join our fast-paced and dynamic team to deliver this cutting-edge therapy to our patients. Key Responsibilities:
Partner with Operations teams to support production activities related Advanced Therapy products in a cGMP manufacturing facility. Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies. Participate in continuous improvement activities. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. Maintain a sufficient inventory of materials necessary for daily functions. If necessary, support adjacent QA groups with record issuance and management. Other duties may be assigned as necessary. Qualifications:
Education: A minimum of a Bachelor's Degree in a scientific field Experience and Skills:
Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required. Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems. Preferred:
Cell and Gene Therapy Experience CAR-T and/or Lentiviral vector manufacturing or QA Experience Experience and/or knowledge of Aseptic techniques Ability to learn and use various systems including eLIMS, COMET, SAT is highly desirable Other:
Tuesday - Saturday first shift 8:00AM - 4:30PM May require up to 10% domestic travel Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.