QC Specialist, Lab Services

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

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for QC Specialist, Lab Services to be in Raritan, NJ.

Purpose: 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.

 

 You will be responsible for: 

• 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 / Requirements:

EDUCATION AND EXPERIENCE:

• 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
• Candidate must be able to accommodate 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

Additional Information:

The anticipated base pay range for this position is $59,000 to $74,000.

 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