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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Key Responsibilities:

• Manage analyst schedule to support Product Release and Environmental Monitoring activities
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Review/approve documents as a QC department subject matter expert (SME)
• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
• Ensure accuracy and completeness of executed analytical method transfer activities
• Set testing priorities and manage work assignments
• Maintain individual training completion in a compliant state
• Mentor, train and supervise quality control staff
• Evaluate performance and provides opportunities for growth.
• Support internal and Health Authority audits
• Support audit related investigations

Qualifications

Education:

• A minimum of a Bachelor’s degree or University equivalent in Scientific discipline is required. Major in Biology, Microbiology and Chemical is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of experience in a regulated manufacturing industry.
• A minimum of 4 years working in a Supervisory role in a laboratory.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or system
• Experience with Nonconformance, CAPA, Audit Observations, and initiates and maintains interplant communications of quality issues.
• Prior People Leader experience.
• Advanced Business English proficiency

Preferred:

• Experience with LIMs and SAP or equivalent systems
• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing
• Japanese knowledge