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Johnson & Johnson Innovative Medicine · 14 hours ago

QA Incoming Inspection Specialist II (3 openings)

Raritan, NJ

Full-time

Onsite

Entry, Mid Level

$65K/yr - $105K/yr

2+ years exp

Johnson & Johnson is a leader in healthcare innovation dedicated to improving health for humanity. The QA Incoming Inspection Specialist II will ensure quality releases of materials for CAR-T and viral vector production, acting as a liaison for internal quality organizations to enhance compliance and address quality concerns.

Pharmaceuticals

Responsibilities

Responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products and viral vectors for clinical trials and commercial operation

Reviews, inspection, and disposition of all incoming materials for use of CAR-T and viral vector product manufacturing per inspection plan and record results to complete receipt process

Review inspection documentation (C of A or other Material Certifications) for inbound materials

Review and inspect documentation in support of Final Product Shipments

Generates inspection reports and non-conformances for failures

Ensures non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented

Track investigations to ensure timely closure

Provide Quality Oversight to Warehouse for cGMP compliance through spot checks/internal audits

Support execution of technical protocols

Participate in departmental or multi-functional, interdepartmental teams and meetings

Support External/Internal Audits

Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance

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

Other duties may be assigned as necessary

Qualification

CGMP regulationsFDA/EU guidanceQuality AssuranceBiotechnology experiencePharmaceutical experienceInterpersonal skillsAttention to detailTeamworkWritten communicationIndependent work

Required

A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred

Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry

Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance

Ability to be organized and capable of working in a team environment with a positive demeanor

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

Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred

Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))

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