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!
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/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
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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.
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
Experience and Skills:
Required:
- Minimum of two (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 demonstrated ability to work cross-functionally
Preferred:
- 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
Other:
- Requires up to 10% domestic travel
- The salary for this role is anticipated to be between $60,000 and $97,750
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)).
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 houper 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
- Work, Personal and Family Time - up to 40 hours per calendar year
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.