Description

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst I, Quality Control - Stability Lab!

About Johnson & Johnson

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 Analyst I is responsible for conducting stability testing in accordance with applicable procedures, standards, and GMP regulations in a safe work environment. They may also be responsible for the support of process improvements, new technologies, automated quality systems, and the transfer of new methods.

Key Responsibilities:

• Conduct general analytical testing of stability samples submitted to the QC laboratories on an as-needed basis
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as needed
• Review statistical analysis, data trending, and reporting
• Contribute to improvements or support quality & compliance and/or process improvement projects related to Stability Operations
• Responsible for initiating Quality Issues for OOS / OOT stability issues, engaging with J&J Lead Statistical SMEs for statistical support of lab investigations and test plans, where required
• Complete and approve corrective and preventative actions (CAPA) as assigned, as well as independently execute and lead change control process
• Participate in internal / external audits and interact with Health Authorities during inspections and lead in discussions demonstrating a proficiency of lab systems, products, and technologies

Qualifications

Education:

• Minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related scientific field is required

Skills & Experience:

Required:

• At least 2 years of relevant experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
• Basic knowledge of cGMP compliance relevant to a QC laboratory work environment
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Basic technical writing skills
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
• Excellent written and verbal communication skills, with demonstrated ability to work cross-functionally

Preferred:

• Understanding and knowledge of current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (cGLP)
• Knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, TOC, FTIR, or pH meters
• Work experience with electronic Laboratory Inventory Management Systems (eLIMS)
• Technical writing experience (e.g., SOPs, Work instructions, TMD, Protocol/Validation reports) and the ability to read/interpret technical documents
• Experience, training, or certification with Process Excellence tools and methodologies

Other:

• Requires up to 10% domestic travel
• Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing

Additional Information:

• The anticipated base pay range for this position is $50,000 to $90,000 annually.
• This position is overtime eligible
• Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: 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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