Quality Assurance Supervisor, 3rd shift

Johnson Johnson; Gurabo (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Johnson & Johnson in Gurabo, PR, is seeking a Quality Assurance Supervisor for the 3rd shift to lead the QA Auditors and supervise batch record reviews, disposition activities, and GMP compliance. This role will coordinate with Manufacturing, Packaging, QC, and QA to ensure timely product release and maintain quality standards.

You will drive continuous improvement, support audits, and ensure adherence to cGMPs and company policies, working in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Science required with a focus in biology, chemistry, or related field.
• Minimum of four (4) years of experience in the pharmaceuticals environment with knowledge of cGMPs and regulatory inspections.
• Certified Quality Auditor (CQA) or Green Belt preferred.

Responsibilities

• Direct supervision of the QA Auditors group and coordinate batch record review, continuous flow processes, quarantine and final disposition.
• Ensure timely batch record review and disposition for raw materials, intermediates, bulk and finished products per supply chain planning values.
• Collaborate with Operations, Logistics, Quality Assurance and QC to resolve compliance issues and ensure on-time product delivery.
• Provide guidance and support to Manufacturing and Packaging Operations to ensure cGMP compliance and adherence to company standards.

Skills

Quality assurance

Regulatory compliance

Auditing

Education

Bachelor's degree in Science

Tools

SAP

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, 3 rd 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