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We are searching for the best talent for QC Lead Analyst to be in Gurabo, PR.

The QC Lead Analyst ensure the conformance of current Good Manufacturing Practices, current JJIM Policies, all pharmacopeias (USP, Ph.Eur, JP and CHP) Standards and Procedures requirements in all activities conducted under Quality Control (QC) Laboratories. The QC Lead Analyst is responsible for establishment and implementation of standard processes to support quality targets are achieved. These include the implementation and/or surveillance on harmonized practices among laboratory areas, assuring compliance with different pharmacopoeia and regulations. Support the process excellence activities in the QC laboratory including the execution of projects that increase process efficiencies, reduce cycle time, and improve overall quality execution. Support of the laboratory scheduling/planning process to address planning exceptions requests. Owner for the implementation of pharmacopeia changes and training requirements.

Maintains of current Standard Operation Procedure (SOP), Work Instruction (WI), creation of new procedures contributing to the continuous improvement principles. Supports internal/external Audit process and initiatives to improve current process and ensure compliance with Regulatory Agencies. The incumbent candidate should be able to work and/or lead teams, communicate properly and influence others.

You will be responsible for:

• Keep the alignment JJIM Gurabo internal procedure with current JJIM QC Global
• Standards and all pharmacopeias (USP, Ph.Eur, JP and CHP) Standards and Procedures requirements and any other applicable documentation.
• Lead the creation of changes associated to current QC procedures in order to optimize QC Gurabo harmonization efforts.
• Assess laboratory performance processes, evaluate gaps, identify processes improvements, and recommend solutions that lead to improvement in efficiency and Support Quality Risk Management efforts in QC.
• Initiates and review Change Controls to support planning changes.
• Provides input for Standard Operating Procedures revisions. Authors, revises SOP’s, and departmental forms and routes for approvals.
• Meet with internal and external organizations such as PDMS, Business excellence, external laboratories, Stability organizations, global teams, etc to achieve resolution of outstanding issues impacting the QC laboratory operations.
• Determines along with QC team, corrective and preventive actions using the appropriate root cause analysis tools. Evaluates the effectiveness of the corrective actions.
• Maintains reliability metrics with the scheduling system.
• Participates in audits. Supports regulatory agency interactions.
• Participate in Supply Review Meetings. Support Planning requests/exceptions by connecting with laboratory areas to adjust laboratory schedules and plans.
• Documents and revises work performed according to company procedures and applicable regulations.
• Trains personnel in various functional areas as required focused in pharmacopoeia
• Back-up responsibilities for Analytical Laboratory Supervisors/Managers.

Qualifications

Education

• A minimum of a Bachelor’s degree in Chemistry is required.

Experience and Skills

Required

• A minimum of 6 years of pharmaceutical experience and knowledge in compliance QC laboratory systems.
• Be familiarized with Pharmacopeias and GMPs and regulatory requirements for pharmaceuticals, and auditing process.
• Have excellent technical writing skills.
• Good interpersonal skills, the ability to manage complexity and disagreements.
• Strong problem solving and decision-making skills and the ability to influence others regarding quality goals.
• Project Management and Leadership skills.
• Bilingual (English and Spanish).
• Computer and software skills.

Preferred

• Knowledge of Domestic and International Regulatory Requirements
• Lean/Six-Sigma Business Excellence Certification

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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