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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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson and Johnson Innovative Medicine, is recruiting for a QA Associate II! This position will be located in Malvern, PA or Spring House, PA!

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 https://www.jnj.com/innovative-medicine

On this team, we provide end to end quality oversight of GMP R&D laboratories responsible for analytical testing of clinical and pre-clinical products in the biotherapeutics product portfolio, equipment life-cycle management, critical reagents, and material specifications. 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 Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.

• Collaborate with business partners to support process development studies.

• Perform regularly scheduled oversight of R&D GxP laboratories.

• Review and approve raw material and critical reagent release for use across the Johnson and Johnson Innovative Medicine global network.

• 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.

• Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment.

• Support 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 with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.

Required:

At least 2 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

• Ability to maintain written records of work performed in paper-based and computerized quality systems.

• 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.

• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

• Working knowledge of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies.

Preferred

• Experience with quality support in large molecule GxP laboratories and or clinical/GMP large molecule manufacturing including risk assessments, change controls, and Non-Conformance investigations including OOS/OOT events.

• Working knowledge of GLP regulations.

• Working knowledge of Phase Appropriate GMP practices.

• Working knowledge of automated/autonomous laboratory validation strategies

• Working knowledge of robotics used within a laboratory setting including

• Technology integration

• Qualification

• Data Mapping

• Validation

• Batch Release

• Knowledge of ATMP regulations and Good Tissue Practices

• Experience with document reviews and regulatory inspection processes is preferred.

• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.

Other:

This position is located primarily in Malvern, PA, but will require up to 20% domestic travel to the Johnson and Johnson Innovative Medicine site in 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 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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.

Johnson and Johnson Innovative Medicine, is recruiting for a QA Associate II! This position will be located in Malvern, PA or Spring House, PA!

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 https://www.jnj.com/innovative-medicine

On this team, we provide end to end quality oversight of GMP R&D laboratories responsible for analytical testing of clinical and pre-clinical products in the biotherapeutics product portfolio, equipment life-cycle management, critical reagents, and material specifications. 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 Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.

• Collaborate with business partners to support process development studies.

• Perform regularly scheduled oversight of R&D GxP laboratories.

• Review and approve raw material and critical reagent release for use across the Johnson and Johnson Innovative Medicine global network.

• 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.

• Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment.

• Support 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 with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.

Required:

At least 2 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

• Ability to maintain written records of work performed in paper-based and computerized quality systems.

• 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.

• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

• Working knowledge of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies.

Preferred

• Experience with quality support in large molecule GxP laboratories and or clinical/GMP large molecule manufacturing including risk assessments, change controls, and Non-Conformance investigations including OOS/OOT events.

• Working knowledge of GLP regulations.

• Working knowledge of Phase Appropriate GMP practices.

• Working knowledge of automated/autonomous laboratory validation strategies

• Working knowledge of robotics used within a laboratory setting including

• Technology integration

• Qualification

• Data Mapping

• Validation

• Batch Release

• Knowledge of ATMP regulations and Good Tissue Practices

• Experience with document reviews and regulatory inspection processes is preferred.

• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.

Other:

This position is located primarily in Malvern, PA, but will require up to 20% domestic travel to the Johnson and Johnson Innovative Medicine site in 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 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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.