Senior Specialist, External Quality

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Specialist, External Quality position based in Horsham, Pennsylvania.

Please note that a preferred candidate has been identified; however, all qualified applicants will be considered.

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

Position Overview

The Senior Specialist External Quality role will be supporting the centralized batch release team by perform batch release for US based external contract manufacturers (DS, DP & Pack sites). Individuals will support standardizing the release process while driving efficiency and improving compliance.

Responsibilities:

• Support the establishment of centralized batch release process for EQ LM NA

• Generation of batch release reports and forms

• Systematic review of batch release documentation

• Coordination of batch release timelines and priorities with planners, EQ account owners, and QPs and ensure adherence to release schedules

• Maintain GMP release packets in documentation management system

• Management and closure of change controls

• Review investigations provided by CMO

• Write internal investigations as related to MDLD's

• Support APR generation and approval

• Collaborate and assist in development of release dashboards

• Oversee sample management as it is related to releases

Minimum Qualifications:

• Bachelor's degree in engineering, science, or an equivalent technical field is preferred

• A minimum of 6 years' experience working in Quality, Technical Operations, Manufacturing and/or similar area within pharmaceuticals, biotech, or medical device industry is required

• Experience in communicating issues to all levels of the organization is required

• Experience in Batch release, Change Controls and Deviations

Essential Qualifications:

• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production is required

• Strong interpersonal and written/oral communication skills is required

• Ability to quickly process complex information and make critical decisions with limited information is required

• Proven experience with all dosage forms is preferred

• Experience investigating product quality complaints is preferred

• Proficient in applying process excellence tools and methodologies is preferred

• Up to 10% domestic travel may be required

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

#Li-Hybrid

Required Skills:

Preferred Skills:

Good Manufacturing Practices (GMP), Quality Assurance (QA)

The anticipated base pay range for this position is :

$94,000 - $151,800

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.