Senior Specialist, External Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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 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 MDLDs

Support APR generation and approval

Collaborate and assist in development of release dashboards

Oversee sample management as it is related to releases

Minimum Qualifications :

Bachelors 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 () 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 :

$94000 - $151800

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 corporations performance over a calendar / performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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.

Required Experience :

Senior IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 94000 - 151800