QC Specialist, Lab Services

lthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://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:

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://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 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://https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
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 i
Additional Description for Pay Transparency:
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://https://www.careers.jnj.com/employee-benefits