QC Analyst, Microbiology (CAR-T)

Johnson & Johnson Innovative Medicine • Raritan, NJ

1d • $65,000 - $104,650 • Onsite

About The Position

Johnson & Johnson is currently recruiting for a QC Analyst, Microbiology- CAR-T. This position will be located in Raritan, NJ with a Wednesday- Saturday 1st shift. Responsible for completing QC testing and environmental monitoring related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom or laboratory environment.

Requirements

• A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required or a minimum of four (4) years of relevant work experience years within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in a Quality Control setting.
• Aseptic processing in ISO 5 clean room and biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products.
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment for microbiological testing/assays. (Endotoxin, EM, Bioburden)
• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC Microbiology.
• Comprehensive knowledge of trending using statistical analysis.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Proficiency in computer systems including LIMS or equivalent.
• The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Responsibilities

• Responsible for completing QC testing and environmental monitoring related to the manufacturing. of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Create, review and approve QC documents SOP's, WI's, FRM's.
• Support Aseptic Process Simulations and visual inspections.
• Maintain Grade B/C gowning.
• Perform Environmental Monitoring and Critical Utility Sampling.
• Perform release assays: Mycoplasma, Endotoxin and Sterility (BAC-T).
• Perform Growth promotion, Subculture, Gram Stain and Microbial Identifications.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems for execution/documentation of testing.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Train QC analysts, operators or other employees.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance. Manufacturing Operations and Analytical/Process Development.
• Available to work off hours or on weekends- dependent on business needs.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level