Quality Assurance Associate III
Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate III located in Malvern, PA!
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 https://www.jnj.com/.
In this role, you will be responsible for providing quality oversight for technology transfer and new product introductions related to the production of large molecule biotherapeutic products for use in clinical trials in a controlled cGMP environment. You will serve as the QA point of contact for various transfers identifying risks and communicating to the broader Quality teams required activities and timelines. 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.
Key
Responsibilities:
Partner with Research & Development and GMP Operations teams to successfully transfer large molecule products and processes into the cGMP facility.
Provide QA support for routine validation maintenance programs and project related changes.
Review and approve controlled documents including standard operating procedures, master batch records, work instructions, controlled drawings, validation protocols and reports, and technical studies.
Provide quality oversight of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance.
Support change management processes including formal change controls by evaluating the proposed changes, documenting impact assessments, and providing feedback on implementation plans.
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.
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 discipline.
Experience and Skills:
Required:
A minimum of four (4) years of relevant industry experience is required.
Ability to be organized and capable of working in a team environment with a positive attitude under minimal direction.
Ability to work in a controlled processing environment (ISO 7/8).
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred:
Experience with quality support in clinical manufacturing or New Product Introduction.
Experience in qualification, validation, and/or equipment lifecycle management.
Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of large molecule biotherapeutics.
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.Estimated Salary: $20 to $28 per hour based on qualifications.
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 https://www.jnj.com/.
In this role, you will be responsible for providing quality oversight for technology transfer and new product introductions related to the production of large molecule biotherapeutic products for use in clinical trials in a controlled cGMP environment. You will serve as the QA point of contact for various transfers identifying risks and communicating to the broader Quality teams required activities and timelines. 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.
Key
Responsibilities:
Partner with Research & Development and GMP Operations teams to successfully transfer large molecule products and processes into the cGMP facility.
Provide QA support for routine validation maintenance programs and project related changes.
Review and approve controlled documents including standard operating procedures, master batch records, work instructions, controlled drawings, validation protocols and reports, and technical studies.
Provide quality oversight of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance.
Support change management processes including formal change controls by evaluating the proposed changes, documenting impact assessments, and providing feedback on implementation plans.
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.
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 discipline.
Experience and Skills:
Required:
A minimum of four (4) years of relevant industry experience is required.
Ability to be organized and capable of working in a team environment with a positive attitude under minimal direction.
Ability to work in a controlled processing environment (ISO 7/8).
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred:
Experience with quality support in clinical manufacturing or New Product Introduction.
Experience in qualification, validation, and/or equipment lifecycle management.
Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of large molecule biotherapeutics.
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.Estimated Salary: $20 to $28 per hour based on qualifications.
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