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.
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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
Johnson & Johnson is currently recruiting for a Quality Assurance Associate ||. This position will be located 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. Johnson and Johnson Innovative Medicine a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Associate II, to be 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/.
On this team, we provide end to end quality oversight of GMP clinical supply laboratories responsible for analytical and microbiologic testing of clinical products in the biotherapeutics and advanced therapy product portfolios. 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:
- Provides Quality review/approvals and guidance associated with investigations (non-conformances), change controls, protocols, reports, SOPs, area releases, project planning and site procedures.
- Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
- Partner with key stakeholders including QC, QA Operations, AD, to support analytical method qualification, validation, and method transfer to facilitate analysis of pre-clinical, clinical, and commercial products as needed.
- 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.
- Perform regularly scheduled oversight of QC laboratories.
- Coordinates, maintains, reports and drives metrics.
- Acts as SME for Quality-focused systems/projects.
- Provides training for Quality concepts or systems.
- Monitors non-conformance and commitment data for trends.
- Proactively evaluates and facilitates remediation of compliance risks.
- Provides Quality/Compliance guidance and recommendations to site personnel.
- Participates in quality audits, Inspection activities and responses.
- Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, and OSHA.
- 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 3 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 clinical/GMP manufacturing or support of GXP laboratories.
- Working knowledge of cGXP regulations.
- Working knowledge of Phase Appropriate GMP practices.
- 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 may require up to 20% domestic travel to the Janssen 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills: **
Preferred Skills: