Lenti Change Control Specialist

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$63,000 - $101,430•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/innovative-medicine We are searching for the best talent for a Lentiviral Change Control Specialist to join our Team! This is an onsite/hybrid role.

Requirements

An Associate’s degree with at least four (4) years of related experience OR a Bachelor’s degree with at least two (2) years of related experience is required.
Ability to read, analyze, and interpret procedure manuals, common scientific / technical journals, basic financial reports and legal documents, general business periodicals, and government regulations
Excellent written and oral communication skills to respond to critical inquiries or complaints from top managers, regulatory agencies, or members of the business community
Experience with internal and/or external regulatory audits
Experience with quality investigations, including root-cause analysis of Non conformance events
Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations
Experience within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

Nice To Haves

Agile Manufacturing
Analytics Dashboards
Chemistry, Manufacturing, and Control (CMC)
Communication
Data Compilation
Data Savvy
Execution Focus
Gap Analysis
Good Manufacturing Practices (GMP)
Issue Escalation
Operational Excellence
Pharmaceutical Industry
Plant Operations
Proactive Behavior
Problem Solving
Process Optimization
Project Administration
Quality Auditing

Responsibilities

Support process changes arising from updates to equipment, materials, excipients or finished goods requirements
Support efforts to establish and streamline the site change control process
Act as change control champion for operations by owning the change control from Initiation through completion
Participate in global forums/team meetings for Change control
Run reports and conduct data analysis to support establishment and monitoring of change control for operations.
Be responsible for authoring, reviewing and approving relevant LV manufacturing and equipment documents, MBR’s, SOP’s, FRM’s, TMD’s and WI’s
Be responsible for analyzing and updating controlled documents for inconsistencies, gaps or errors to drive process quality improvement
Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES updates.
Lead implementation of corrections / CPAs by working with SMEs, Correction/ CPA owners, and tech writers to maintain timelines.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

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