QA Lab Oversight Specialist II - Johnson and Johnson

Johnson & Johnson is recruiting for a QA Lab Oversight Specialist, located in Raritan, NJ!

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/.

The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories. The responsibility includes providing quality support for pre-clinical, clinical, and commercial stage CAR-T cellular therapy product quality control testing.
Key Responsibilities:

• Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with local site and global J&J policies.
• Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility to test products.
• Review and approve GMP documents as applicable.
• Support the release of patient sample materials.
• Perform spot-checks in the QC Laboratories to ensure compliance.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Recognize patterns/trends in shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities.
• Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
• Support the timely closure of quality issues.
• Act as liaison for the quality team to guide project and strategy execution.
• Learn and develop within the business as a Subject Matter Expert on quality assurance topics.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Education:

• Minimum of a Bachelor's Degree required; focused degree in Science or Engineering Technologies preferred.

Experience and Skills:

Required:

• A minimum of 2 years GMP work experience is required.
• Ability to quickly process information and make critical decisions with minimal oversight.
• Ability to pay attention to details and adhere to project timelines.
• The candidate must be highly organized and capable of working in a team environment with a positive approach under minimal supervision.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)

Preferred:

• Experienced in cGMP aseptic manufacturing environments, preferably in production, quality control or quality assurance.
• Experience with cell and/or gene therapy.
• Experience with Quality management systems including: Trackwise, Comet, Compliance wire, ELIMS, MES, PASx.

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 9:00 AM- 5:00 PM Wednesday- Saturday, and provide occasional support including other shifts with little or no prior notice.
• This position is anticipated to have up to 10% travel
• The anticipated base pay range for this position is $61,000 to $97,750.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar

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 www.careers.jnj.com .
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