Quality Assurance Supervisor, 3rd shift

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

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Gurabo, Puerto Rico, United States of America

Job Description: About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Quality Assurance Supervisor, 3rd shift to be located in Gurabo, PR.

Key Responsibilities:

• Responsible of direct supervision of the QA Auditors group and coordinates the overall activities of the batch record review, continuous flow processes, quarantine and final disposition.
• Coordinates Operations (Manufacturing and/or Packaging) Audits.
• Assures timely and reliable batch record review and disposition activities of raw materials, intermediate stages, bulk and finished products as per Supply Chain planning values.
• Establish cycle times then monitors and measures against standards.
• Ensures that assigned Batch Record Review process outcomes are achieved in accordance with Supply Chain goals and objectives.
• Ensures that assigned product disposition outcomes are achieved in accordance with Supply Chain goals and objectives.
• Ensures batch record review / continuous flow/ quarantine processes are executed in accordance with c-GMPs, Company Global Standards, Company Policies, Quality Agreements and current procedures.
• Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to solve potential compliance issues in a proactive way in order to deliver product on time.
• Make the appropriate recommendations and decisions to prevent process and/or product deviations.
• Supports the Senior Quality Assurance Manager to drive quality and personnel objectives to the established Company and QA Area/Department goals and objectives.
• Provides technical guidance and compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, Company Global Standards, Company Policies, Quality Agreements, Batch Records, current specifications and current procedures.
• Identify and evaluate related documentation such as but not limited to Investigations, Change Controls, and Protocols, Reports, Validation documents, Forms and Cleaning Validation Notifications to determine materials and / or product quality of a batch before conducting continuous flow into the next operational step.
• Takes disciplinary actions with direct reports if applicable in alignment with Human Resources Policies and Procedures.
• Assure equipment cleaning at risk documentation (Cleaning Validation Notifications) have been properly documented in SAP System as a flagging item for the Order Release Group.
• Support the Cycle time reduction in batch records review and release.
• Assure that products are approved on time and to minimize product backorder situations related to Product Disposition performance.
• Participate in GEMBA and Kaizen Teams to avoid backorders and to deliver product on a timely manner.
• Provide immediate actions and support in the timely resolution of quality and compliance matters that may include but not limited to product segregation, product recalls and product approval/rejection.
• Update SAP System with batch status change of a product under investigation that should not be further processed that may require physically segregation/ identification accordingly.

Qualifications:

• A 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.
• This position requires availability for working third shift, including irregular shifts and weekends.
• Frequently requires working extended hours and might be required to work on holidays.
• This position requires up to ten percent (10%) of domestic travel.

Preferred Skills:

• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross-Functional Collaboration
• Detail-Oriented
• Developing Others
• Give Feedback
• Goal Attainment
• Human-Centered Design
• Inclusive Leadership
• Internal Controls
• Leadership
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Risk Assessments

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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/.

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