QC Specialist, Lab Services

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Quality Control Specialist, Lab Services-CAR-T! This position will be 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 QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:

• Prepares and reviews documentation independently.
• Responsible for QC sample and retain management
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)
• Prepare documents and coordinate Sample shipment (internal and external shipments)
• Review logbooks and/ or LIMs to align physical quantities of samples in freezers
• Periodic inspection and consolidation of retains
• Document and perform sample management related non-conformance investigations
• Document and handle corrective and preventative action records
• Supports internal and regulatory audits
• Perform offsite visual inspection of retains annually

Qualifications

Education:

A minimum of a Bachelor's or equivalent University degree is required, with a focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field preferred.

Required:

• A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry [in QC sample & retain management
• Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process

Preferred:

• Solid understanding of regulatory requirements, policies and guidelines
• Experience with Quality Control document reviews and regulatory inspection processes
• Working knowledge of Quality systems
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint), and LIMS

Other:

• This position may require up to 10% domestic travel.
• This position may occasionally require heavy lifting up to 20 pounds.
• The ability to accommodate a schedule of Sunday to Wednesday, from 4:00P to 2:00A, there will be a 12% differential for this position
• This position has an estimated annual salary of 61,000-110,000 USD$.

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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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 year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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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