Current Vacancy in Johnson & Johnson – Lab Compliance Specialist

Job Description:

The Lab Compliance Specialist is responsible for the analytical data management and technical execution of day-to-day Quality Control activities for the NJ Stability laboratories, ensuring GMP compliance, accuracy, and timeliness of specified testing processes.

Job Responsibilities:

• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as needed
• Optimize equipment calibration/preventative maintenance schedules.
• Complete and approve corrective and preventative actions (CAPA) as assigned, as well as independently implement and lead change control process
• 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
• Train/Mentor laboratory personnel, serve as SME for local or global stability-related procedures; may serve as periodic reviewer for such procedures, and to ensures these procedures are kept current in compliance with current regulations, industry practices, and J&J/JSC Standards/Policies
• 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
• Lead improvements or support quality & compliance and/or process improvement projects related to Stability Operations
• Statistical analysis, data trending, and technical writing for Laboratory deliverables and process improvements

Job Requirements:

• Working experience in a cGMP compliant QC laboratory or equivalent environment
• Knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, TOC, FTIR, or pH meters
• Strong understanding and knowledge of current Good Manufacturing Practices (cGMP)
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
• Work experience with electronic Laboratory Inventory Management Systems (eLIMS)
• Experience working directly with collaborators under limited supervision
• Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
• Experience, training or certification with Process Excellence tools and methodologies
• Minimum of five (5) years of relevant work experience
• Technical writing experience (e.g., SOPs, Work instructions, TMD, Protocol/Validation reports) and the ability to read/interpret technical documents
• Excellent written and verbal communication skills

Job Details:

Company: Johnson & Johnson

Vacancy Type: Full Time

Job Location: Raritan, NJ, US

Application Deadline: N/A

Apply Here