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Product Quality Specialist

Johnson & Johnson Innovative Medicine · Horsham, PA · 3 wk ago
Hybrid$79k–$128k/yrFull-time

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.

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.

Purpose

The Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products.

Responsibilities

  • Stability POC for a set of product families (API and Drug Product)
  • Oversight of Sample management for stability
  • Author/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy
  • Support audits and filings as appropriate related to stability questions
  • Responsible for stability Lifecycle management
  • Supports PQI/PQO and Business Partners with stability related questions
  • Support temperature excursions, change controls, stability notifications and escalations as applicable
  • Maintain stability statements for assigned products
  • Partner with Stability Labs as needed to ensure questions are addressed in a timely manner
  • Active Member of Stability CoE:
    • Support departmental goals
    • Give input on topics raised in staff meetings to support continued improvement of stability processes

Requirements

  • Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required
  • A minimum of 6 years of relevant experience is required
  • A minimum of 4 years’ experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience)
  • Experience in API and drug product stability and business implications regarding stability decisions is desired
  • Understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required
  • Insight in pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus
  • Demonstrated ability to work independently and in a team environment
  • Relationship building as part of a team is required
  • Strong written and oral communication skills with various levels of the organization
  • Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations
  • Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time
  • This position may require up to 5-10% domestic and international travel as business demands

Pay

The anticipated base pay range for this position is $79,000.00 - $127,650.00.

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)).

  • 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

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