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Quality Assurance Associate II
4 weeks ago
Janssen Biotech, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II This position will 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
On this team, we provide end to end quality oversight of GMP Quality Control Laboratories responsible for analytical testing of commercial and clinical products. 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:
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 GMP manufacturing and/or QC Testing.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 10% domestic travel to the Janssen site in Spring House, PA.Employees and/or eligible dependents may be eligible to participate in Company sponsored employee benefit programs.
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
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