- Partner with QC Laboratory Teams to provide QA oversight support of analytical method transfers, raw material testing and release, commercial and clinical product release, and stability testing activities.
- Perform regularly scheduled oversight of the QC Laboratories.
- Author and revise quality departmental documents as needed.
- 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.
- Support 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 QC 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 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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Quality Assurance Associate II - Malvern, United States - Johnson & Johnson
Description
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:
