What are the responsibilities and job description for the QA ASSOCIATE II position at Johnson & Johnson?
Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II, Quality Operations based out of 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 (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.
In this role, you will be performing QA Batch Release activities and providing Quality Oversight of daily activities related to the production of commercial and clinical materials for designated manufacturing sites. The QA Batch Release Associate ensures compliance with cGMPs and is responsible for performing batch record review and release activities. Additionally, the associate will be responsible for regular scheduled quality oversight walkthroughs. 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.
RESPONSIBILITIES
- Review and approve commercial and clinical batch records and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies
- Coordinate and perform release activities for intermediate and final drug substance.
- Provide quality input on a variety of compliance related issues and attend meetings as a quality representative.
- Partner with Operations teams to schedule and perform quality oversight within manufacturing, warehouse, and QC labs to ensure inspection readiness at all times.
- Author and revise quality departmental documents.
- Review and approve controlled documents including standard operating procedures, master batch records, work instructions, and technical documents.
- Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
- Participate in process improvement activities including assessing current processes, providing improvement input, and working with partners to implement changes.
- Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.
- Other duties may be assigned as necessary.
Qualifications
- A minimum of a Bachelor’s Degree is required, preferably in Engineering, Science or equivalent technical discipline.
- A minimum of 2 years of proven experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
- Ability to work in an aseptic processing environment is required.
- 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.
- Ability to maintain written records of work performed in paper-based and computerized quality systems is required.
- Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of biopharmaceutical products is preferred.
- This position is located in Malvern, PA and may require up to 10% local travel. Are you willing and able to meet these requirements?
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
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.
Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Organization
Janssen Biotech, Inc. (6014)
Job Function
Quality
Requisition ID
2206007842W
Salary : $0
