3rd Shift QA Lead – Batch Review & Compliance

2162-Janssen Ortho LLC Legal Entity; Gurabo (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Johnson & Johnson in Gurabo, PR seeks a Quality Assurance Supervisor (3rd shift) to oversee QA auditors, manage batch record reviews, and ensure compliant disposition of materials and products. The role requires deep cGMP knowledge and cross-functional collaboration to meet Supply Chain goals.

Will supervise QA activities, drive continuous improvement, and support the Senior QA Manager in achieving quality metrics. Bilingual English/Spanish and 4+ years in pharma QA are essential.

Qualifications

• Bachelor's or higher degree in Science is required with a majors in Microbiology, Biology, Chemistry or related science preferred.
• A minimum of four (4) years of experience in the Pharmaceuticals environment with knowledge of cGMP's, record control specifications, and experience in regulatory inspections is required.
• Requires overall experience in the Quality Assurance Unit.
• Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications are highly preferred.
• Knowledge or experience in Oral Solid Dosage forms manufacturing and packaging processes is required.
• Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols is required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) is required.
• Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), LIMS is preferred.
• Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
• Proficiency in both languages English and Spanish (oral and written) is required.

Responsibilities

• Responsible for direct supervision of the QA Auditors group and coordinates batch record review, continuous flow processes, quarantine and final disposition.
• Coordinates Operations (Manufacturing and/or Packaging) Audits.
• Ensures timely and reliable batch record review and disposition activities of raw materials, intermediate stages, bulk and finished products.
• Establish cycle times then monitors and measures against standards.
• Ensures batch record review/continuous flow/quarantine processes are executed in accordance with cGMPs and company standards.
• Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to solve potential compliance issues.
• Provide recommendations to prevent process and/or product deviations.
• Support Senior QA Manager to drive quality and personnel objectives.
• Provide technical guidance and compliance support to Manufacturing and Packaging Operations.
• Identify and evaluate related documentation to determine materials and/or product quality for a batch.
• Take disciplinary actions with direct reports per HR policies.
• Ensure cleaning documentation in SAP is properly recorded.
• Support cycle time reduction in batch records review and release.
• Ensure products are approved on time and minimize backorders.
• Participate in GEMBA and Kaizen Teams to avoid backorders.

Skills

Quality Assurance

cGMP

Auditing

SAP

TrackWise

LIMS

Microsoft Office

Bilingual English/Spanish

Education

Bachelor's degree in Science

CQA (Certified Quality Auditor) preferred

Green Belt / Lean Manufacturing / Kaizen preferred

Tools

SAP

Compliance Wire

Documentation System

Investigation System (TrackWise)

LIMS

Job description

Johnson & Johnson in Gurabo, PR seeks a Quality Assurance Supervisor (3rd shift) to oversee QA auditors, manage batch record reviews, and ensure compliant disposition of materials and products. The role requires deep cGMP knowledge and cross-functional collaboration to meet Supply Chain goals.

Will supervise QA activities, drive continuous improvement, and support the Senior QA Manager in achieving quality metrics. Bilingual English/Spanish and 4+ years in pharma QA are essential.