Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst II, Quality Control - Stability Lab In Raritan, NJ!
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The J&J Supply Chain is an integrated, global supply chain that serves the needs of the 1 billion people who use J&J products each and every day around the world. We manufacture more than 26 billion product units per year, from raw component sourcing to end product distribution as efficiently and effectively as possible with high quality, compliance and service performance. Our supply chain organization makes up 45% of all J&J employees, and includes 125 internal manufacturing plants, manages 581 external manufacturers, utilizes 459 distribution centers, partners with over 3700 direct suppliers, produces over 300,000 sku’s.
The Analyst II 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.
- 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 implement 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
- Minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related scientific field is required
Experience and Skills:
- Minimum of 2 years of relevant work experience
- Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
- Working experience in a cGMP compliant QC laboratory or equivalent environment
- Experience participating in internal or external audits and/or health authority inspections
- Proficiency with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Excellent written and verbal communication skills, with proven ability to work cross-functionally
- Strong 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
- Requires up to 10% domestic travel
- Requires the physical ability to lift up to 20lbs, 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
- The anticipated salary range for the role is expected to be between $60,000 to $85,000.
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 .