Associate Analyst, QC Microbiology - LVV

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan Township (ND); On-site; USD 54,000 - 87,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Paid vacation

Sick leave

Holiday pay

Parental Leave

Bereavement leave

Volunteer leave

Military leave

Job summary

Johnson & Johnson in Raritan, New Jersey is seeking an Associate Analyst, QC Microbiology – LVV to join the Quality Control team responsible for environmental monitoring and testing in a cell therapy manufacturing facility.

You will work with a team to perform environmental monitoring, plate reads, endotoxin testing, and support process improvements while ensuring compliance with cGMP and GDP standards in an ISO 5 cleanroom environment.

Qualifications

• Bachelor's degree or equivalent in Biological Science or related field.
• 0-1 years of relevant work experience in biotech/pharma.
• Knowledge of microbiology testing and sampling methods.
• Aseptic processing experience in ISO 5 cleanroom preferred.
• Solid understanding of cGMP and GDP.

Responsibilities

• Lab support and equipment cleaning.
• Participating in LVV manufacturing facility commissioning and qualification.
• Perform routine environmental monitoring of classified LVV areas.
• Perform endotoxin testing of raw materials.
• Support process improvements and data verification/approval.
• Operate in accordance with safety policies and GMP requirements.

Skills

Microbiology knowledge

Communication skills

ISO 5 cleanroom experience

cGMP knowledge

Education

Bachelor's degree in Biological Science or related field

Tools

eLIMS

GDP

GMP

Job description

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America

Job Description: About Innovative Medicine

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. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Analyst, QC Microbiology – LVV. The Microbiology Lentivirus Vector (LVV) Manufacturing QC Associate Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and supporting process improvements. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5-15 other associates within the functional Quality Control laboratory and Manufacturing area. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products?

Key Responsibilities

• Lab support and equipment cleaning
• Participating in LVV manufacturing facility commissioning and qualification.
• Performing Routine Environmental Monitoring of classified areas within the Raritan LVV Facility.
• Performing compressed gas sampling in the LVV manufacturing facility.
• Performing environmental monitoring, APQ, and plate reads.
• Perform endotoxin testing of raw materials.
• Participating in gown qualification and re-qualification of personnel.
• Supporting Aseptic Process Simulations and visual inspection of components.
• Utilizing electronic systems (eLIMS) for execution and documentation of testing.
• Perform peer data verification/approval of laboratory data.
• Supporting process improvement teams.
• Performing tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications

Education Minimum of a Bachelor's degree or equivalent required; a focused degree in Biological Science or an equivalent technical field preferred.

Experience and Skills Required

• Minimum of 0-1 years of relevant work experience.
• Experience in the biological and/or pharmaceutical industry.
• Microbiology experience related to manufacturing.
• Detailed knowledge of microbiology testing and sampling methods, techniques, and related equipment preferred.
• Experience with aseptic processing in an ISO 5 cleanroom and/or biosafety cabinets.
• Knowledge of cGMP regulations, Good Documentation Practices (GDP), and FDA/EU guidance related to the manufacturing of cell-based products is required.
• Excellent written and verbal communication skills.
• Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision.

Preferred

• Experience in a Quality Control setting.
• Experience working with cell therapy.
• Knowledge of FDA/EU guidance related to the manufacturing of cell-based products, as well as knowledge of Good Tissue Practices (GTP).

Other

• Requires the ability to work in a cleanroom environment and the ability to lift up to 20 pounds.
• Requires the ability and flexibility to accommodate unplanned overtime (including nights and weekends) with little to no prior notice.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check #LI-Onsite Required Skills: Preferred Skills: Accountability, Administrative Support, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Process Oriented, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Teamwork, Technologically Savvy

Pay

The anticipated base pay range for this position is : $54,000.00 - $87,400.00

Benefits

• Subject to the terms of their respective plans, 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 period10 days Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.

Do Not Sell or Share My Personal Information Limit the Use of My Personal Information