Johnson & Johnson-posted 5 days ago
$94,000 - $151,800/Yr
Full-time • Mid Level
Raritan, NJ
5,001-10,000 employees

At Johnson & Johnson, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. This position is responsible for interfacing with internal manufacturing sites and external partners that collect Apheresis Material and perform Cryopreservation activities used in autologous CAR-T products for clinical trials and commercial treatment in resolution of non-conformances. Job duties are performed within a team schedule and collaboration with key partners.

  • Provide Quality resolution of non-conformance oversight to apheresis/cryopreservation facilities.
  • Monitor trends, identify issues, recommend, and implement appropriate actions.
  • Perform duties under limited supervision and according to standard operating procedures.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP/GTP requirements.
  • Coordinate and provide concurrences on deviations, change controls, and CAPAs.
  • Other duties will be assigned, as the need arises.
  • Minimum of a bachelor’s degree in science, Medical or equivalent technical field is required.
  • Minimum of 5 years industry related experience is required.
  • Experience providing quality oversight of a pharmaceutical manufacturing, laboratory, or clinical study site is required.
  • Good written and verbal communication skills are required.
  • Critical thinking skills and ability to focus on detail is required.
  • Knowledge of cGMP regulations preferred.
  • Understanding of Data Analytics to drive performance preferred.
  • employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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