QC Analyst, Microbiology (LVV)

Johnson & Johnson • Raritan, NJ

1d • Onsite

About The Position

At J&J Innovative Medicine, we are working to create a world without disease. Transforming 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. We are J&J Innovative Medicine. We collaborate with the world for the health of everyone in it. Learn more at www.jnj.com/innovativemedicine.

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 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.
• Other duties assigned as necessary.
• 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
• 10 days 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: Mid Level