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Job Title: QA ASSOCIATE III
Company Name: Johnson & Johnson
Location: Malvern, PA United States
Position Type: Full Time
Post Date: 08/13/2022
Expire Date: 10/12/2022
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Finance/Economics, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Writing/Authoring
Job Description
QA ASSOCIATE III

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Associate III in Malvern, PA!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.

In this role, you will be providing quality oversight of Quality Control laboratories responsible for analytical testing of commercial and clinical products in 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.

Main responsibilities will include, but are not limited to:

  • Partner with Quality Control teams to support analytical method transfers, commercial and clinical product release and stability testing activities, and raw material testing and release.
  • Perform regularly scheduled oversight of the QC laboratories.
  • Review paper and electronic laboratory documentation for completeness and accuracy.
  • 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

Education:

  • A minimum of a Bachelor’s Degree is required, preferably in Engineering, Science or equivalent technical field.

Experience and Skills:

Required:

  • 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
  • Knowledge of cGMP regulations and FDA/EU guidance.
  • Ability to maintain written records of work performed in paper-based and computerized quality systems.
  • Ability to work independently on complex issues with minimal supervision.
  • Ability to be organized and capable of working in a team environment with a positive demeanor.
  • A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

Preferred:

  • Experience with quality support in clinical manufacturing or support of QC laboratories
  • Knowledge of ATMP regulations and Good Tissue Practices.

Other

  • This position is located primarily in Malvern, PA and
  • This position will require up to 10% local travel to Spring House, PA.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

 


Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2206065572W
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Contact Information
Company Name: Johnson & Johnson
Website:https://jobs.jnj.com/jobs/2206065572W?lang=en-us&src=HBCUConnect
Company Description:

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