Janssen Global Services, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Assurance Analyst II – 3 Shift to be located in Vacaville, CA.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information
This Quality Assurance Analyst II will:
· Performs audits of manufacturing processes, records and facilities against current Good Manufacturing Practices, Standard Operating Procedures, and applicable Health Authority regulations.
· This individual will partner with Manufacturing and other support groups to provide issue guidance and resolution in alignment with applicable procedures.
· This individual will provide QA oversight for the Event process, and will perform review and closure of Events.
· This individual is expected to identify systemic issues and collaborate and participate with the Process Centered Organization (PCO) to implement solutions.
· Perform audits of manufacturing processes, records and facilities.
· Provide real- time issue guidance and resolution, including management of Events.
· Involvement in continuous improvement activities or other projects to support site goals.
· Training (maintenance of compliance and personal development).
· Support of internal, partner and agency audits and other tasks as assigned.
· Facilitate training for others.
· Other assigned duties as needed.
This position requires a minimum of a high school diploma and 3+ years related experience. A Bachelor’s Degree is preferred.
Must have a good understanding of cGMPs, compliance and quality in a pharmaceutical manufacturing environment.
The individual must be able to coordinate Event investigation activities through closure, and identify compliance gaps with minimal guidance.
Knowledge of Solids, OROS, and Transdermal manufacturing processes is desirable.
Must have good verbal and written communication skills and be able to prioritize workload in a constantly changing environment.
Must possess the ability to use personal computers and standard software applications found in a professional business setting.
Must be flexible and have strong interpersonal skills and be able to collaboratively work with personnel from other groups.
Must be highly organized.
Will be required to work any schedule that aligns with the business needs of the company (In this case, 3 Shift).
This position is located in Vacaville, CA and may require some travel.