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QA Associate II
Quality
Malvern / United States of America
QA Associate II
Apply now
Save
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Job title
QA Associate II
Function
Quality
Sub function
Quality Assurance
Category
Analyst, Quality Assurance (P4 - E24)
Location
Malvern / United States of America
Date posted
Apr 28 2026
Requisition number
R-071716
Work pattern
Hybrid Work
This job posting is anticipated to close on May 08 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for a QA Associate II to be based in Malvern, PA.
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.
Learn more at
Purpose: In this role, you will be providing quality oversight of R D GxP laboratories, Raw Material Release, and the Clinical Supply Chain warehouse responsible for analytical testing of clinical products, Raw Material handling/release, and Cell Bank CofA approvals for the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
You will be responsible for:
Partner with R D GxP laboratories, Cell Banking, Warehouse (clinical supply) to support analytical method transfers, clinical product and raw material release activities.
Partner with R D GxP/GMP teams to support process development studies.
Perform regularly scheduled oversight of the R D GxP laboratories and Warehouse.
Review paper and electronic laboratory documentation for completeness and accuracy.
Review critical alarms for appropriate response actions.
Review and approve certificates of analysis where required.
Author and revise quality departmental documents.
Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.
Provide quality oversight for sample management activities.
Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts.
Other duties may be assigned as necessary.
Qualifications/Requirements:
A minimum of a Bachelor's Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.
At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.
Working Knowledge of cGMP regulations and FDA/EU guidance is required.
Experience with Quality document reviews and regulatory inspection processes is preferred.
Ability to maintain written records of work performed in paper-based and computerized quality systems is required.
Ability to work independently on routine tasks and require some supervision on complex issues.
Ability to be organized and capable of working in a team environment with a positive demeanor is required.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills are required.
This position is located primarily in Malvern, PA and will require up to 15% local travel to Spring House, PA.
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 & 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:
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Equal Employment Opportunity Posters | GINA Supplement
Do not sell or share my personal information
Limit the use of my sensitive personal information
Johnson & Johnson and its affiliates 2026
Medicines & therapies
Medical devices & technology
Media
Contact
View saved jobs
0
English
Login
Healthcare areas
News
Investors
Careers
Our company
Search J&J.com
Home
Careers
Jobs
QA Associate II
Quality
Malvern / United States of America
QA Associate II
Apply now
Save
Share job
Job title
QA Associate II
Function
Quality
Sub function
Quality Assurance
Category
Analyst, Quality Assurance (P4 - E24)
Location
Malvern / United States of America
Date posted
Apr 28 2026
Requisition number
R-071716
Work pattern
Hybrid Work
This job posting is anticipated to close on May 08 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for a QA Associate II to be based in Malvern, PA.
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.
Learn more at
Purpose: In this role, you will be providing quality oversight of R D GxP laboratories, Raw Material Release, and the Clinical Supply Chain warehouse responsible for analytical testing of clinical products, Raw Material handling/release, and Cell Bank CofA approvals for the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
You will be responsible for:
Partner with R D GxP laboratories, Cell Banking, Warehouse (clinical supply) to support analytical method transfers, clinical product and raw material release activities.
Partner with R D GxP/GMP teams to support process development studies.
Perform regularly scheduled oversight of the R D GxP laboratories and Warehouse.
Review paper and electronic laboratory documentation for completeness and accuracy.
Review critical alarms for appropriate response actions.
Review and approve certificates of analysis where required.
Author and revise quality departmental documents.
Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.
Provide quality oversight for sample management activities.
Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts.
Other duties may be assigned as necessary.
Qualifications/Requirements:
A minimum of a Bachelor's Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.
At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.
Working Knowledge of cGMP regulations and FDA/EU guidance is required.
Experience with Quality document reviews and regulatory inspection processes is preferred.
Ability to maintain written records of work performed in paper-based and computerized quality systems is required.
Ability to work independently on routine tasks and require some supervision on complex issues.
Ability to be organized and capable of working in a team environment with a positive demeanor is required.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills are required.
This position is located primarily in Malvern, PA and will require up to 15% local travel to Spring House, PA.
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 & 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:
Similar jobs
Sr Mgr QA Operations
Quality
Sassenheim
Save
Senior QA Associate Commercial
Quality
Geel
Save
Assoc. Dir., Transcend R D Data Mgmt.
R D Operations
Malvern / Horsham
Save
Careers in North America
Discover career opportunities at J&J locations in the United States and Canada.
Not ready for a new role right now?
No worries. Join our talent community and we'll reach out when we post new jobs that may match your interests and skills so you can apply when the time is right.
Locations
North America
Europe, Middle East & Africa
Asia Pacific
Latin America
Medicines & therapies
Products
Oncology
Neuroscience
Immunology
Cardiopulmonary
Medical devices & technology
Products
Cardiovascular
Orthopaedics
Surgery
Vision
About us
Our company
Medicines & therapies
Medical devices & technology
Careers
Investors
Media
Key links
Terms of use
Privacy
Cookie policy
Customize Cookie Settings
Request disability accommodation
Hiring FAQs
Employment policies
E-Verify
Recruitment fraud notice
Get in touch
Contact us
Equal Employment Opportunity Posters | GINA Supplement
Do not sell or share my personal information
Limit the use of my sensitive personal information
Johnson & Johnson and its affiliates 2026
Job ID: 519760848
Originally Posted on: 5/3/2026
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